← Back to catalogue

MetaFix™

FDA UDI

Class I (US FDA UDI)

by Merete GmbH

Identity

Trade Name
MetaFix™ FDA UDI
Generic Name
Cannulated surgical drill bit, reusable FDA UDI
Device Name
MetaFix I Drill Bit DIA 2.0 mm Length 150 mm AO-Connector with Stopping unit non-sterile FDA UDI
Model / Reference
FH10002 FDA UDI
Description
MetaFix I Drill Bit DIA 2.0 mm Length 150 mm AO-Connector with Stopping unit non-sterile FDA UDI

Identifiers

Primary DI / UDI-DI
04048266040084 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
Cannulated surgical drill bit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
Not 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

MetaFix™ by Merete GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Merete GmbH

Sources (1)

  • FDA UDI eee2e121-36d0-4a58-a231-5c91725662ff 35 fields · synced May 30, 2026