Omnia Medical Piranha 04-5C-PDR1

GUDID 00843511101268

Plate Shield Driver

OMNIA MEDICAL, LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00843511101268
NIH Device Record Key932e9e59-9498-4a04-a111-54ee0484bc01
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnia Medical Piranha
Version Model Number04-5C-PDR1
Catalog Number04-5C-PDR1
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
GS100843511101268 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843511101268]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-10
Device Publish Date2020-04-02

Devices Manufactured by OMNIA MEDICAL, LLC

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00843511102043 - Omnia Medical TiBrid™-C2024-03-22 CONVEX RASP, 05mm
00843511102050 - Omnia Medical TiBrid™-C2024-03-22 CONVEX RASP, 06mm
00843511102067 - Omnia Medical TiBrid™-C2024-03-22 CONVEX RASP, 07mm
00843511102074 - Omnia Medical TiBrid™-C2024-03-22 CONVEX RASP, 08mm
00843511102081 - Omnia Medical TiBrid™-C2024-03-22 CONVEX RASP, 09mm
00843511102098 - Omnia Medical TiBrid™-C2024-03-22 CONVEX RASP, 10mm

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