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OMNIBotics

FDA UDI

Class II (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name
OMNIBotics FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
Self-tapping and self-drilling bone screw Ø4mm, L150mm, thread 45mm FDA UDI
Model / Reference
4148-1001 FDA UDI
Description
Self-tapping and self-drilling bone screw Ø4mm, L150mm, thread 45mm FDA UDI

Identifiers

Catalog Number
4148-1001 FDA UDI
Primary DI / UDI-DI
00841690199892 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

No

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

No

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 prosthesis implantation positioning instrument, reusable

OMNIBotics by OMNIlife science, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OMNIlife science, Inc.

Sources (1)

  • FDA UDI 058e797e-b769-4257-94ba-ce22e3e3ad3e 35 fields · synced Jun 9, 2026