Identity
- Trade Name
- A.T.S.® 3000 FDA UDI
- Generic Name
- Surgical pneumatic tourniquet system FDA UDI
- Device Name
- A.T.S. 3000 LOP Sensor Assembly FDA UDI
- Model / Reference
- 60-3000-105-00 FDA UDI
- Description
- A.T.S. 3000 LOP Sensor Assembly FDA UDI
Identifiers
- Catalog Number
- 60-3000-105-00 FDA UDI
- Primary DI / UDI-DI
- 00889024209091 FDA UDI
- FDA Product Code
- KCY FDA UDI
- GMDN Term
- Surgical pneumatic tourniquet system 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
No
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
Yes
FDA UDI
Category: Surgical pneumatic tourniquet system
A.t.s.® 3000 by Zimmer Orthopaedic Surgical Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical pneumatic tourniquet system.
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- DTS-3000 — DAESUNG MAREF CO., LTD. · Class I
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- PTSii Personalized Tourniquet System Kit, Twin — Delfi Medical Innovations Inc · Class I
- LiveBand BFR — INNOVATION INSTITUTE, LLC · Class I
- PTSii Personalized Tourniquet System (Red) — Delfi Medical Innovations Inc · Class I
- DTS-3000 — DAESUNG MAREF CO., LTD. · Class I
- Zimmer Tourniquet — RENU MEDICAL, INC · 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
- Zimmer Orthopaedic Surgical Products
Sources (1)
- FDA UDI 114f19d7-c1f4-4c57-a38c-25a841ec6457 35 fields · synced May 30, 2026