Stryker Tourniquet

Basic Information

• Brand Name: Stryker Tourniquet
• Primary DI: 00816317022648
• Version / Model: RM-5921-024-135
• Company Name: RENU MEDICAL, INC
• Labeler DUNS: 100439103
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-31
• Public Version: 5
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 9eebd255-fd6c-421c-be50-f3084d7f654b
• Distribution End Date: 2023-08-23

Device Description

Stryker Color Cuff II Adt 30x4in. 5921-030-135

Device Characteristics

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

Sterilization

• Is Sterile: No
• 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
Primary	00816317022648	GS1
Package	10816317022645	GS1	case	10	Not in Commercial Distribution	2023-08-23