Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- Limb tourniquet, manual, single-use FDA UDI
- Device Name
- Tourniquet, SAM XT, Extremity Tourniquet, by Curaplex, Black FDA UDI
- Model / Reference
- XT605-BK-EN FDA UDI
- Description
- Tourniquet, SAM XT, Extremity Tourniquet, by Curaplex, Black FDA UDI
Identifiers
- Catalog Number
- SAM XT-BM FDA UDI
- Primary DI / UDI-DI
- 00810071636097 FDA UDI
- FDA Product Code
- GAX FDA UDI
- GMDN Term
- Limb tourniquet, manual, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5900 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
No
FDA UDI
Over-the-Counter
Yes
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: Limb tourniquet, manual, single-use
Curaplex by Bound Tree Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Limb tourniquet, manual, single-use.
- Centurion — Centurion Medical Products · Class I
- SOF® TOURNIQUET GEN 4, COLOR-BLUE — TACTICAL MEDICAL SOLUTIONS, LLC · Class I
- Dealmed — DEALMED MEDICAL SUPPLIES LLC · Class I
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class I
- Resilient Medical Solutions — Resilient Medical Solutions, LLC · Class I
- ASP MEDICAL — Asp Global, LLC · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Centurion — Centurion Medical Products · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI 6cce1f34-6a5c-46f9-965e-060bdb821b7a 34 fields · synced Jun 8, 2026