Stryker

Basic Information

• Brand Name: Stryker
• Primary DI: 10817357021179
• Version / Model: 5921-034-235
• Company Name: HYGIA HEALTH SERVICES, INC.
• Labeler DUNS: 177939027
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-04
• Public Version: 2
• Public Version Date: 2021-03-19
• Public Version Status: Update
• Public Device Record Key: e81b2af0-49d0-4b56-80fa-5f30a6cc7ef2
• Distribution End Date: 2019-07-31

Device Description

34" x 4" Stryker Cuff - Purple - Single Bladder - Dual Port - QC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	878.5910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61825	Tourniquet cuff, reprocessed	A sterile, 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30817357021173	GS1	Box	10	Not in Commercial Distribution	2021-03-19
Primary	10817357021179	GS1