Broach, Femoral, Actera, Size 01

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name: BROACH, FEMORAL, ACTERA, SIZE 01 FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: ACTERA FEMORAL BROACH SIZE 01 FDA UDI
Model / Reference: 1080-676 FDA UDI
Description: ACTERA FEMORAL BROACH SIZE 01 FDA UDI

Identifiers

Catalog Number: 1080-676 FDA UDI
Primary DI / UDI-DI: 00810933031442 FDA UDI
FDA Product Code: MEH FDA UDI
OQG FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 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

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: Orthopaedic broach

Broach, Femoral, Actera, Size 01 by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Conformis, Inc.

Sources (1)

FDA UDI 81d19c08-6d48-4647-ad27-5d45c5e74e44 35 fields · synced Jun 8, 2026