← Back to catalogue

OMNIBotics

FDA UDI

Class I (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name
OMNIBotics FDA UDI
Generic Name
Knee tibia prosthesis trial, reusable FDA UDI
Device Name
Unity Insert Trial, Sz 7B FDA UDI
Model / Reference
NS-5057B FDA UDI
Description
Unity Insert Trial, Sz 7B FDA UDI

Identifiers

Catalog Number
NS-5057B FDA UDI
Primary DI / UDI-DI
00841690195504 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Knee tibia prosthesis trial, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 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

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: Knee tibia prosthesis trial, reusable

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

Similar devices

Also classified as Knee tibia prosthesis trial, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
OMNIlife science, Inc.

Sources (1)

  • FDA UDI 137454c5-6489-4bdc-a473-9bd8573458e7 35 fields · synced Jun 9, 2026