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BOSS Instruments

FDA UDI

Class I (US FDA UDI)

by Boss Instruments, Ltd.

Identity

Trade Name
BOSS Instruments FDA UDI
Generic Name
Orthopaedic chisel FDA UDI
Device Name
Dahmen-Lexer Chisel, 20mm wide, 8 5/8" FDA UDI
Model / Reference
70-3470 FDA UDI
Description
Dahmen-Lexer Chisel, 20mm wide, 8 5/8" FDA UDI

Identifiers

Catalog Number
70-3470 FDA UDI
Primary DI / UDI-DI
00888515152830 FDA UDI
FDA Product Code
FZO FDA UDI
GMDN Term
Orthopaedic chisel 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic chisel

BOSS Instruments by Boss Instruments, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic chisel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boss Instruments, Ltd.

Sources (1)

  • FDA UDI 0332cbdb-78d6-4748-bd95-c130289bc42c 35 fields · synced Jun 9, 2026