GUDID - Information Request Form

Device Identifier (DI) Information

Issuing Agency

Primary DI Number

Device Count (if the UDI for the device not available but on the base package)

Unit of Use DI Number (DI Number assigned for single device, if more than one device in primary package)

Labeler DUNS Number

Company Name

Company Physical Address

Brand Name (The Proprietary/Trade/Brand name that is typically registered with USPTO and have the ® and/or TM symbol.)

Version or Model. Catalog Number can be entered if device does not currently have a Version or Model. If the device does not have a version, model or catalog number, enter a concept that can be used to identify all devices that have specifications, performance, size, and composition within limits set by the labeler.

Catalog Number (optional)

Device Description (any description found on the device label to support user comparison of the device label to the GUDID device record information , for e g .about the devices packaged within the convenience kit)(Optional)

DI Record Publish Date

Commercial Distribution End Date (Optional)

Commercial Distribution Status

Alternative or Additional Identifiers

Direct Marking DI number. If device required for direct marking and different from primary DI.

Secondary DI (If device has two UDI numbers from two issuing agency)

Issuing Agency(Optional)

Secondary DI Number (Optional)

Package DI

Package DI Number ;If device is available in higher levels of packaging

Quantity per Package. Required If Package DI is entered

Contains DI Package. Required If Package DI is entered

Package Type (Optional)

Package Discontinue Date (If Package DI Number and Commercial Distribution End Date are entered, must also enter Package Discontinue Date)

Package Status

Customer Contact

Customer Contact Phone

Customer Contact Email

Device Status

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

Yes

No

Kit

Yes

No

Combination Product

Yes

No

Premarket

Device Exempt from Premarket Submission (Required if Premarket Submission Number OR exempt status fulfills regulatory requirement.)

Yes

No

FDA Premarket Submission Number (Required if Premarket Submission Number OR exempt status fulfills regulatory requirement.)

Supplement Number (Required if Premarket Submission Number OR exempt status fulfills regulatory requirement.)

FDA Product Code

Product Code (Required Unless device is a kit or IVD with a BL premarket submission number)

Product Code Name

FDA Listing

FDA Listing Number (Required Unless device is an HCT/P with a BL premarket submission number)

GMDN

Code

Name

Definition

Device Characteristics

For Single-Use

Yes

No

Production Identifier(s) in UDI

Lot or Batch Number is present on label

Yes

No

Manufacturing Date

Yes

No

Serial Number

Yes

No

Expiration Date

Yes

No

Donation Identification Number

Yes

No

Latex Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437).

Yes

No

Device labeled as "Not made with natural rubber latex"(Optional)

Yes

No

Prescription Status

Prescription Use (Rx) (Optional)

Yes

No

Over the Counter (OTC) (Optional)

Yes

No

MRI Safety Status

What MRI safety information does the labeling contain?

MR Safe

MR Unsafe

MR Conditional

Labeling does not contain MRI Safety information

Clinically Relevant Size

Size Type (Required If device is available in more than one size)

Size Value (Required If device is available in more than one size)

Size Unit of Measure (Required If device is available in more than one size)

Size Type Text (Required If device is available in more than one size)

Storage and Handling

Storage and Handling Type (Optional)

Low Value (Required One value (Low or High) is required if Storage and Handling Type is added to the device record)

High Value (Required One value (Low or High) is required if Storage and Handling Type is added to the device record)

Unit of Measure (Required if Storage and Handling Type is added to the device record)

Special Storage Conditions (Required if 'Special Storage Conditions' is selected above)

Sterilization Method

Device Packaged as Sterile

Yes

No

Requires Sterilization Prior to Use

Yes

No

Sterilization Method (Required if 'Requires Sterilization Prior to Use' is marked 'Yes')

Submitter Name*

Job Title*

Submitter E-mail*

GUDID - Information Request Form

Register with FDA