AccessGUDID - DEVICE: Stryker (10817357022473)

GUDID

Device Identifier (DI) Information

Brand Name: Stryker
Version or Model: 5921-024-135
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HYGIA HEALTH SERVICES, INC.

Primary DI Number: 10817357022473
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 177939027 *Terms of Use

Device Description: 24" x 4" Stryker Cuff - Yellow - Single Bladder - Single Port - QC

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):	No
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?
61825	Tourniquet cuff, reprocessed	A band-like device intended to be applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or following serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff may comprise a dual-chamber allowing alternation of the pressure site to avoid tissue damage or necrosis. This is a previously used single-use device that has been processed for an additional single-use patient application.	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
No Device Sizes

Device Record Status

Public Device Record Key: ab9afd24-9f55-431a-9a79-f003ee458441
Public Version Date: November 07, 2024
Public Version Number: 3
DI Record Publish Date: March 02, 2018