SynFix

FDA UDI

Class I (US FDA UDI)

by Synthes

Identity

Trade Name: SynFix FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: SYNFIX-LR TRIAL RASP 12DEG DEPTH 30MM/W 38MM/H 12MM FDA UDI
Model / Reference: SD397.073 FDA UDI
Description: SYNFIX-LR TRIAL RASP 12DEG DEPTH 30MM/W 38MM/H 12MM FDA UDI

Identifiers

Catalog Number: SD397073 FDA UDI
Primary DI / UDI-DI: 10705034709543 FDA UDI
FDA Product Code: HTR FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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: Bone file/rasp, manual, reusable

SynFix by Synthes — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Synthes

Sources (1)

FDA UDI d0f47a8d-1cf7-4255-a1ee-41c16b7935a3 35 fields · synced Jun 8, 2026