AccessGUDID - DEVICE: NA (20681490042455)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 1532520
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 20681490042455
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 835465063 *Terms of Use

Device Description: SHEET 1532520 10PK SILICONE 5X5CM 1.02MM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61557	Silicone-sheet tissue reconstructive material	A flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive surgery applications (e.g., repair of nasal septum or orbital floor, perforated eardrum, or hernia/fissure of abdominal wall).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KHJ	POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970910	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Thickness is 1 MM

Device Record Status

Public Device Record Key: 1dc82074-13ea-426c-881a-6672cdba1ec1
Public Version Date: August 15, 2025
Public Version Number: 5
DI Record Publish Date: July 17, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00681490042451 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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