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Zimmer® Universal Power System

FDA UDI

Class I (US FDA UDI)

by Gebr. Brasseler GmbH & Co. KG

Identity

Trade Name
Zimmer® Universal Power System FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Device Name
Radiolucent Drill 3.2 x 106 mm, Tri-Fluted, ZMH Shank FDA UDI
Model / Reference
89-8508-042-32 FDA UDI
Description
Radiolucent Drill 3.2 x 106 mm, Tri-Fluted, ZMH Shank FDA UDI

Identifiers

Catalog Number
89-8508-042-32 FDA UDI
Primary DI / UDI-DI
14053613171912 FDA UDI
FDA Product Code
GFG FDA UDI
GMDN Term
Orthopaedic bur, single-use 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic bur, single-use

Zimmer® Universal Power System by Gebr. Brasseler GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bur, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gebr. Brasseler GmbH & Co. KG

Sources (1)

  • FDA UDI 44fe7c77-1d03-433c-a63b-940b804ad31f 34 fields · synced May 30, 2026