AccessGUDID - DEVICE: N/A (00889024367371)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 00-0057-001-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00-0057-001-00
Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Primary DI Number: 00889024367371
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 137354267 *Terms of Use

Device Description: Serrated Clips

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:	No
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?
34957	Surgical drape clip, reusable	A surgical instrument with two blades joined at their midpoint or made from a single alpha-shaped part, designed to temporarily attach or hold a drape(s), or to hold a drape to other devices, during a surgical procedure. It is typically designed with flat gripping blades so as not to harm the material of the drape. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HST	Apparatus, Traction, Non-Powered

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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: f1fc3831-b72d-4fc5-b6d4-5d0cb0609207
Public Version Date: September 11, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2020