AccessGUDID - DEVICE: N/A (00889024377905)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 60-8000-012-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-8000-012-00
Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Primary DI Number: 00889024377905
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137354267 *Terms of Use

Device Description: ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF PROTECTIVE SLEEVE (FOR USE WITH ZIMMER 12 IN. (30 CM) DISPOSABLE CUFF)

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":	Yes
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?
47949	Tourniquet cuff bandage, non-latex	A sterile strip or roll of non-latex containing material that is applied around an extremity (arm or leg) before the fitting of a tourniquet cuff on top of it. This device is used to protect the patient's skin from wrinkling, pinching or shearing and to protect the tourniquet cuff from becoming soiled with blood and other fluids from the operative site. It would typically be folded back over the exposed edges of the cuff to provide maximum protection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCY	Tourniquet, Pneumatic

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: 12 Inch

Device Record Status

Public Device Record Key: 6fa88280-8a1d-4b3a-8f21-49b6beb57ef4
Public Version Date: November 15, 2021
Public Version Number: 1
DI Record Publish Date: November 05, 2021