FDA.reportPublic FDA data

N/A

Primary DI
50885825016277
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
N/A
Catalog number
5921-115-235
Device description
Tourniquet Color Cuff Dual Port, Single Bladder (Pink), Quick Connect
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCYTOURNIQUET, PNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCYTourniquet, PneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885825016277PackageGS110In Commercial Distribution
00885825016272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088582501627750885825016277
00885825016272008858250162728858250162720885825016272

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, reprocessedA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference15Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327666878N/ALXMJ23LLXMJ23L2026-06-25
07613327666885N/ALXMJ23SLXMJ23S2026-06-25
07613327666892N/ALXMJ44SLXMJ44S2026-06-25
07613327666908N/ALXMJ37SLXMJ37S2026-06-25
07613327666915N/ALXMJ44LLXMJ44L2026-06-25
07613327666922N/ALXMJ37LLXMJ37L2026-06-25
07613327688788N/APSCIC101PSCIC1012026-04-06
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
00850043377092Aquamantys23-112-123-112-12024-05-16
00850043377085Aquamantys23-313-123-313-12024-05-16
00850043377108Aquamantys23-113-123-113-12024-05-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
00885825011703N/AN/A4083092016-09-23
00885825011710N/AN/A4083102016-09-23
00885825011727N/AN/AG4083242016-09-23
07613327663365N/AHAR723HAR7232025-08-27
07613327663389N/AHAR736HAR7362025-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489106015MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106022MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106039MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106046MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106053MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10193489106060MEDLINEMEDLINE INDUSTRIES, INC.KCY2025-10-15
10080196374854MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
10080196379187MEDLINE RENEWALMEDLINE INDUSTRIES, INC.KCY2025-02-14
08809802644052Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644069Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644076Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644083Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644090Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644106Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644113Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644120Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644137Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644144Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644151Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644168Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644175Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644182Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644199Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644205Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644212Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
08809802644229Tourniquet CuffDAESUNG MAREF CO.,LTD.KCY2023-06-16
96973521872753N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-06-12
96973521872777N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-06-12
96973521872272N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-05-31
96973521872289N/AShenzhen Vistar Medical Supplies Co.,Ltd.KCY2023-05-31