Tournevis

FDA UDI

Class I (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name: TOURNEVIS FDA UDI
Generic Name: Joint prosthesis implantation kit, reusable FDA UDI
Model / Reference: APA06851 FDA UDI

Identifiers

Catalog Number: APA06851 FDA UDI
Primary DI / UDI-DI: M684APA068511 FDA UDI
FDA Product Code: HWE FDA UDI
GMDN Term: Joint prosthesis implantation kit, reusable 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

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: Joint prosthesis implantation kit, reusable

A comprehensive medical device directory entry for the TOURNEVIS instrument, a general purpose surgical instrument used for cutting and forming bone.

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DFS — Biomet Orthopedics, Inc. · Class II

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: MicroPort Orthopedics Inc.

Sources (1)

FDA UDI 3cf1753a-7a24-4e24-8350-588a809cf339 34 fields · synced Jul 2, 2026