Assi

FDA UDI

Class I (US FDA UDI)

by Accurate Surgical & Scientific Instruments Corp.

Identity

Trade Name: ASSI FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: Fomon Rasp, 21cm Double Ended Str., TC Ends 7mm X 40mm, Coarse Grit No.7 & Very Coarse Grit No.8 FDA UDI
Model / Reference: ASSI.112368 FDA UDI
Description: Fomon Rasp, 21cm Double Ended Str., TC Ends 7mm X 40mm, Coarse Grit No.7 & Very Coarse Grit No.8 FDA UDI

Identifiers

Primary DI / UDI-DI: 00841645119319 FDA UDI
FDA Product Code: KBA FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 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

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

Assi by Accurate Surgical & Scientific Instruments Corp. — 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: Accurate Surgical & Scientific Instruments Corp.

Sources (1)

FDA UDI d37eb13c-cda0-4c71-a9a7-31cb950100c0 33 fields · synced May 30, 2026