Omnia Medical PsiF 01-5P-JFR1

GUDID 00843511100674

PsiF Joint Finder Instrument

OMNIA MEDICAL, LLC

Orthopaedic chisel
Primary Device ID00843511100674
NIH Device Record Key1e9d2794-70ba-4a2e-89b4-c317e49908c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnia Medical PsiF
Version Model Number01-5P-JFR1
Catalog Number01-5P-JFR1
Company DUNS079467378
Company NameOMNIA MEDICAL, LLC
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3044134851
Emailcustomerservice@omniamedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511100674 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843511100674]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-24
Device Publish Date2020-01-16

On-Brand Devices [Omnia Medical PsiF]

00843511100681PsiF Impaction Cap Ball Handle
00843511100674PsiF Joint Finder Instrument
00843511100667PsiF Cannula Instrument
00843511100650PsiF Box Cutter Rasp Instrument
00843511100643PsiF Slap Hammer Peg Instrument
00843511100636PsiF Post Packer (Long Impactor) Instrument
00843511100629PsiF Allograft Inserter Instrument
00843511101251PsiF Impaction Cap Handle
00843511100902Orthocision PsiF Box Cutter
008435111013361.4 mm x 130 mm Kwire
00843511121778Kwire, 1.4mm x 460 mm Nitinol, blunt drill
00843511121266Impaction Cap Handle
00843511121228Joint finder
00843511121242Drill Adapter

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