A.t.s.®

FDA UDI

Class I (US FDA UDI)

by Zimmer Orthopaedic Surgical Products

Identity

Trade Name: A.T.S.® FDA UDI
Generic Name: Surgical pneumatic tourniquet system FDA UDI
Model / Reference: 60-1908-001-00 FDA UDI

Identifiers

Catalog Number: 60-1908-001-00 FDA UDI
Primary DI / UDI-DI: 00889024376533 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical pneumatic tourniquet system

A.t.s.® by Zimmer Orthopaedic Surgical Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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LiveBand BFR — INNOVATION INSTITUTE, LLC · Class I
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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 b7757c47-45a5-4310-bc22-9c2affbaf113 34 fields · synced Jun 1, 2026