Sklar

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar FDA UDI
Generic Name: Ophthalmic surgical probe, reusable FDA UDI
Device Name: BOWMAN LACH PROBE 0000/000 FDA UDI
Model / Reference: 65-4098 FDA UDI
Description: BOWMAN LACH PROBE 0000/000 FDA UDI

Identifiers

Primary DI / UDI-DI: 10649111370052 FDA UDI
FDA Product Code: HNW FDA UDI
GMDN Term: Ophthalmic surgical probe, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic surgical probe, reusable

Sklar by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic surgical probe, reusable.

MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
V. Mueller — STERIS CORPORATION · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Titanium Nucleus Splitter — KATALYST SURGICAL, LLC · Class I
Scleral Depressors — AURORA SURGICAL, LLC · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Sklar Corporation

Sources (1)

FDA UDI fb206ae4-2acc-4380-930a-597c8c628327 33 fields · synced Jun 8, 2026