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Unium

FDA UDI

Class I (US FDA UDI)

by Synthes

Identity

Trade Name
UNIUM FDA UDI
Generic Name
Surgical power tool battery-exchange sterility cover FDA UDI
Device Name
UNIUM(TM) STERILE COVER FDA UDI
Model / Reference
05.001.603 FDA UDI
Description
UNIUM(TM) STERILE COVER FDA UDI

Identifiers

Catalog Number
05001603 FDA UDI
Primary DI / UDI-DI
10886982309563 FDA UDI
FDA Product Code
MOQ FDA UDI
GMDN Term
Surgical power tool battery-exchange sterility cover FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical power tool battery-exchange sterility cover

Unium by Synthes — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool battery-exchange sterility cover.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI b45427f6-72cb-48f5-8767-d17f827da9f7 35 fields · synced May 30, 2026