Unity Knee System CK-07192

GUDID 00841690184683

Unity Femoral Inserter

Omni Life Science, Inc.

Orthopaedic implant impactor, reusable
Primary Device ID00841690184683
NIH Device Record Keyaa2c863c-a2bb-497d-97a8-5fbf1e8d62dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnity Knee System
Version Model NumberCK-07192
Catalog NumberCK-07192
Company DUNS061339651
Company NameOmni Life Science, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com
Phone+1(800)448-6664
EmailCS@omnils.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841690184683 [Primary]

FDA Product Code

HWAIMPACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841690184683]

Moist Heat or Steam Sterilization


[00841690184683]

Moist Heat or Steam Sterilization


[00841690184683]

Moist Heat or Steam Sterilization


[00841690184683]

Moist Heat or Steam Sterilization


[00841690184683]

Moist Heat or Steam Sterilization


[00841690184683]

Moist Heat or Steam Sterilization


[00841690184683]

Moist Heat or Steam Sterilization


[00841690184683]

Moist Heat or Steam Sterilization


[00841690184683]

Moist Heat or Steam Sterilization


[00841690184683]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2026-02-09
Device Publish Date2023-01-10

On-Brand Devices [Unity Knee System]

00841690185284Unity Patella Trial Size 1
00841690185277Unity Patella Trial Size 2
00841690185260Unity Patella Trial Size 3
00841690185253Unity Patella Trial Size 4
00841690185246Unity Patella Trial Size 5
00841690185239Unity Sizer, 3 deg
00841690184669Unity Knee Tibial Implant Introducer
008416901846524 in 1 Block Drop in Handle
00841690184683Unity Femoral Inserter

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