AccessGUDID - DEVICE: Silverstein (20681490040802)

GUDID

Device Identifier (DI) Information

Brand Name: Silverstein
Version or Model: 1428005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 20681490040802
Issuing Agency: GS1
Commercial Distribution End Date: December 06, 2023
Device Count: 6
Labeler D-U-N-S® Number*: 835465063 *Terms of Use

Device Description: PACKING 1428005 6PK LONG STRIPS POLYEST

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?
33310	Polyethylene craniofacial tissue reconstructive material	A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NOK	MATERIAL, EXTERNAL AESTHETIC RESTORATION, NO ADHESIVE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Length: 6.4 Millimeter
Width: 50.8 Millimeter

Device Record Status

Public Device Record Key: bcf85cd1-e150-4667-83b4-4c7b4ff138ff
Public Version Date: March 07, 2024
Public Version Number: 4
DI Record Publish Date: October 13, 2017