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Bausch + Lomb

FDA UDI

Class I (US FDA UDI)

by Bausch & Lomb Incorporated

Identity

Trade Name
Bausch + Lomb FDA UDI
Generic Name
Middle ear chisel FDA UDI
Device Name
OSTEOTOME RUBIN 16MM W/FGR GRP FDA UDI
Model / Reference
N4344 FDA UDI
Description
OSTEOTOME RUBIN 16MM W/FGR GRP FDA UDI

Identifiers

Catalog Number
N4344 FDA UDI
Primary DI / UDI-DI
00757770416721 FDA UDI
FDA Product Code
GFI FDA UDI
GMDN Term
Middle ear 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: Middle ear chisel

Bausch + Lomb by Bausch & Lomb Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Middle ear chisel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bausch & Lomb Incorporated

Sources (1)

  • FDA UDI 659d5b94-6c48-4491-931b-473cd8fe8656 34 fields · synced Jun 8, 2026