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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
Plastic surgery osteotome FDA UDI
Device Name
Obwegeser Pterygo-Maxil Osteo, 8mm tip, child, 9" FDA UDI
Model / Reference
85-0196 FDA UDI
Description
Obwegeser Pterygo-Maxil Osteo, 8mm tip, child, 9" FDA UDI

Identifiers

Catalog Number
85-0196 FDA UDI
Primary DI / UDI-DI
00888515223820 FDA UDI
FDA Product Code
EMM FDA UDI
GMDN Term
Plastic surgery osteotome 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

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: Plastic surgery osteotome

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

Similar devices

Also classified as Plastic surgery osteotome.

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 6ec68a14-718c-47cd-a9c1-f65024e28332 35 fields · synced Jun 9, 2026