Stryker Tourniquet ea

GUDID 00816317023782

Stryker Color Cuff II Adt 18x4in. 5921-218-235

RENU MEDICAL, INC

Pneumatic tourniquet system
Primary Device ID00816317023782
NIH Device Record Keyec091a6c-c56b-4600-a859-a9b6ab3ab36a
Commercial Distribution StatusIn Commercial Distribution
Brand NameStryker Tourniquet
Version Model NumberRM-5921-218-235
Catalog Numberea
Company DUNS100439103
Company NameRENU MEDICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816317023782 [Primary]
GS110816317023789 [Package]
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

KCYTourniquet, Pneumatic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-19
Device Publish Date2020-03-11

On-Brand Devices [Stryker Tourniquet]

10861317022720Stryker Color Cuff II Adt 18 x 4in. 5921-218-135
10861317022713Stryker Color Cuff II Ped 12x3.5in. 5921-212-235
10861317022706Stryker Color Cuff II Ped 9x1.75in. 5921-109-135
10861317022690Stryker Color Cuff II Adt 44 x4in. 5921-044-235
10861317022683Stryker Color Cuff II Adt 44 x4in. 5921-044-135
10861317022676Stryker Color Cuff II Adt 34x4in. 5921-034-235
10861317022669Stryker Color Cuff II Adt 34x4in. 5921-034-135
10861317022652Stryker Color Cuff II Adt 30x4in. 5921-030-235
00861317022648Stryker Color Cuff II Adt 30x4in. 5921-030-135
10861317022638Stryker Color Cuff II Adt 24x4in. 5921-024-235
10861317022621Stryker Color Cuff II Adt 24x4in. 5921-024-135
10861317022614Stryker Color Cuff II Adt 18x5in. 5921-018-245
00861317022600Stryker Color Cuff 2 Adult. 18x3 in 5921-018-235
10861317022591Stryker Color Cuff II Adt 18 x 3in. 5921-018-135
00816317023782Stryker Color Cuff II Adt 18x4in. 5921-218-235
10816317022720Stryker Color Cuff II Adt 18 x 4in. 5921-218-135
10816317022713Stryker Color Cuff II Ped 12x3.5in. 5921-212-235
10816317022706Stryker Color Cuff II Ped 9x1.75in. 5921-109-135
10816317022690Stryker Color Cuff II Adt 44 x4in. 5921-044-235
10816317022683Stryker Color Cuff II Adt 44 x4in. 5921-044-135
10816317022676Stryker Color Cuff II Adt 34x4in. 5921-034-235
10816317022669Stryker Color Cuff II Adt 34x4in. 5921-034-135
10816317022652Stryker Color Cuff II Adt 30x4in. 5921-030-235
00816317022648Stryker Color Cuff II Adt 30x4in. 5921-030-135
10816317022638Stryker Color Cuff II Adt 24x4in. 5921-024-235
10816317022621Stryker Color Cuff II Adt 24x4in. 5921-024-135
10816317022614Stryker Color Cuff II Adt 18x5in. 5921-018-245
00816317022600Stryker Color Cuff 2 Adult. 18x3 in 5921-018-235
10816317022591Stryker Color Cuff II Adt 18 x 3in. 5921-018-135
10816317024113Stryker Color Cuff II Adt 30x4in. 5921-030-135
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.