Identity
- Trade Name
- Color Cuff FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- Nonsterile Disposable Tourniquet Cuff, Single Bladder, Single Port and Quick Connect Connector FDA UDI
- Model / Reference
- 5921-218-235NS FDA UDI
- Description
- Nonsterile Disposable Tourniquet Cuff, Single Bladder, Single Port and Quick Connect Connector FDA UDI
Identifiers
- Catalog Number
- 5921-218-235NS FDA UDI
- Primary DI / UDI-DI
- 07613327606164 FDA UDI
- FDA Product Code
- KCY FDA UDI
- GMDN Term
- Tourniquet cuff, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tourniquet cuff, single-use
Color Cuff by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tourniquet cuff, single-use.
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- Pneumatic Tourniquet Cuff — Tiantai Typhung Medical Supplies Co., Ltd · Class I
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- Mobile Stand for Tourniquet — VBM Medizintechnik GmbH · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI fee7f0b6-69ef-4f09-83be-68403830ae29 36 fields · synced May 30, 2026