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Unium

FDA UDI

Class I (US FDA UDI)

by Synthes

Identity

Trade Name
UNIUM FDA UDI
Generic Name
Reaming power tool attachment FDA UDI
Device Name
HUDSON QC FOR REAMING, SBD II / UNIUM(TM) FDA UDI
Model / Reference
05.001.258 FDA UDI
Description
HUDSON QC FOR REAMING, SBD II / UNIUM(TM) FDA UDI

Identifiers

Catalog Number
05001258 FDA UDI
Primary DI / UDI-DI
10886982309624 FDA UDI
FDA Product Code
HWE FDA UDI
GMDN Term
Reaming power tool attachment 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: Reaming power tool attachment

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

Similar devices

Also classified as Reaming power tool attachment.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI 5ff19c89-fbdb-4a90-9c46-4cbfaf4ab96d 35 fields · synced May 30, 2026