Paul Banditt

FDA UDI

Class I (US FDA UDI)

by Terlain Enterprises, Inc.

Identity

Trade Name: Paul Banditt FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: PAUL BANDITT 2301 BONE FILE, CROSS CUT, OCTAGONAL HANDLE, DE FDA UDI
Model / Reference: BFX2301 FDA UDI
Description: PAUL BANDITT 2301 BONE FILE, CROSS CUT, OCTAGONAL HANDLE, DE FDA UDI

Identifiers

Primary DI / UDI-DI: D955BFX23011 FDA UDI
FDA Product Code: EMI FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

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

Paul Banditt by Terlain Enterprises, Inc. — 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: Terlain Enterprises, Inc.

Sources (1)

FDA UDI e6745b11-1989-4bdf-8b2a-57bc54b6c484 33 fields · synced May 30, 2026