Identity
- Trade Name
- ATS 5000TS TOURNIQUET SYSTEMS EUDAMEDA.T.S.® Personalized Pressure® FDA UDI
- Generic Name
- Surgical pneumatic tourniquet system FDA UDI
- Device Name
- ATS5000TS WITH HOSES EUDAMED
- Model / Reference
- 60500010100 EUDAMED60-5000-101-00 FDA UDI
Identifiers
- Catalog Number
- 60500010100 FDA UDI
- Primary DI / UDI-DI
- 00889024626454 EUDAMEDFDA UDI
- Basic UDI-DI
- 889024-ZB001755-GJ EUDAMED
- 510(k) Number
- K202919 FDA UDI
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139006 PNEUMATIC TOURNIQUETS EUDAMED
- GMDN Term
- Surgical pneumatic tourniquet system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tourniquet cuff, single-use
Ats 5000ts Tourniquet Systems by Zimmer Surgical SA — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 889024-ZB001755-GJ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Zimmer Surgical, Inc.
- EUDAMED SRN
- US-MF-000001150
- Authorised Representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
Sources (2)
- EUDAMED 25fce3d3-2ae1-4111-af04-a489967c943c 61 fields · synced Jun 18, 2026
- FDA UDI b2c48c54-c626-4b9e-a98c-131d59779271 35 fields · synced May 30, 2026