Identity
- Trade Name
- SAM® XT Extremity Tourniquet EUDAMEDSAM XT Extremity Tourniquet FDA UDI
- Generic Name
- Arterial tourniquet, manual, single-use FDA UDI
- Device Name
- SAM® XT Extremity Tourniquet EUDAMEDSAM EXTREMITY TOURNIQUET-HI-VIS ORANGE FDA UDI
- Model / Reference
- XT600-OR-EN EUDAMEDFDA UDI
- Description
- SAM EXTREMITY TOURNIQUET-HI-VIS ORANGE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822045000216 EUDAMEDFDA UDI
- Basic UDI-DI
- 0822045XT01WH EUDAMED
- FDA Product Code
- GAX FDA UDI
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
- GMDN Term
- Arterial tourniquet, manual, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5900 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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, reusable
SAM® XT Extremity Tourniquet by SAM Medical Products — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Limb tourniquet, manual, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0822045XT01WH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SAM Medical Products
- EUDAMED SRN
- US-MF-000002589
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 47c546a3-e3e2-4c7b-a573-0ef3292110fb 61 fields · synced Jul 10, 2026
- FDA UDI 4d26e3fa-9bb7-4d8d-9b36-82def751840f 34 fields · synced May 30, 2026