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Omnia Medical Instruments

FDA UDI

Class I (US FDA UDI)

by Omnia Medical

Identity

Trade Name
Omnia Medical Instruments FDA UDI
Generic Name
Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
Device Name
big handled lenke probe FDA UDI
Model / Reference
02-5S-BHL2 FDA UDI
Description
big handled lenke probe FDA UDI

Identifiers

Catalog Number
02-5S-BHL2 FDA UDI
Primary DI / UDI-DI
00843511101374 FDA UDI
FDA Product Code
HXB FDA UDI
GMDN Term
Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

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: Abdominal/ENT/orthopaedic surgical probe, reusable

Omnia Medical Instruments by Omnia Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Abdominal/ENT/orthopaedic surgical probe, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Omnia Medical

Sources (1)

  • FDA UDI b61b0261-94eb-4160-bc1f-c572aa9c8ed5 35 fields · synced Jun 8, 2026