Omnia Medical VBR 06-2V-1215

GUDID 00843511100131

Omnia Medical VBR, 12mm X 12.5mm X 1.5mm Spacer

OMNIA MEDICAL, LLC

Vertebral body prosthesis, non-sterile
Primary Device ID00843511100131
NIH Device Record Key10b8b2c5-575c-4e5a-b3d1-5ed1e54e9952
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnia Medical VBR
Version Model Number06-2V-1215
Catalog Number06-2V-1215
Company DUNS079467378
Company NameOMNIA MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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 Dimensions

Height1.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511100131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal Vertebral Body Replacement Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843511100131]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-10
Device Publish Date2018-02-05

On-Brand Devices [Omnia Medical VBR]

08435111000502Omnia Medical VBR, Short Inserter
08435111000403Omnia Medical VBR, Inserter
08435111000519Omnia Medical VBR, 12mm Tamp
0084351110124477mm Omnia Medical VBR Trial
0084351110123775mm Omnia Medical VBR Trial
0084351110122073mm Omnia Medical VBR Trial
0084351110121371mm Omnia Medical VBR Trial
0084351110120669mm Omnia Medical VBR Trial
0084351110119067mm Omnia Medical VBR Trial
0084351110118365mm Omnia Medical VBR Trial
0084351110117663mm Omnia Medical VBR Trial
0084351110116961mm Omnia Medical VBR Trial
0084351110115259mm Omnia Medical VBR Trial
0084351110092613mm Omnia Medical VBR Trial
0084351110114557mm Omnia Medical VBR Trial
0084351110113855mm Omnia Medical VBR Trial
0084351110112153mm Omnia Medical VBR Trial
0084351110111451mm Omnia Medical VBR Trial
0084351110110749mm Omnia Medical VBR Trial
0084351110109147mm Omnia Medical VBR Trial
0084351110108445mm Omnia Medical VBR Trial
0084351110107743mm Omnia Medical VBR Trial
0084351110106041mm Omnia Medical VBR Trial
0084351110105339mm Omnia Medical VBR Trial
0084351110104637mm Omnia Medical VBR Trial
0084351110103935mm Omnia Medical VBR Trial
0084351110102233mm Omnia Medical VBR Trial
0084351110101531mm Omnia Medical VBR Trial
0084351110100829mm Omnia Medical VBR Trial
0084351110099527mm Omnia Medical VBR Trial
0084351110098825mm Omnia Medical VBR Trial
0084351110097123mm Omnia Medical VBR Trial
0084351110096421mm Omnia Medical VBR Trial
0084351110095719mm Omnia Medical VBR Trial
0084351110094017mm Omnia Medical VBR Trial
0084351110093315mm Omnia Medical VBR Trial
00843511100513Omnia Medical VBR, 12mm Tamp
00843511100506Omnia Medical VBR, Short Inserter
00843511100490Omnia Medical VBR, Case
00843511100483Omnia Medical VBR, 14mm Implant Caddy
00843511100476Omnia Medical VBR, 12mm Implant Caddy
00843511100469Omnia Medical VBR, Endplate Release Tool
00843511100452Omnia Medical VBR, Mallet
00843511100445Omnia Medical VBR, Calipers
00843511100438Omnia Medical VBR, Tamp
00843511100421Omnia Medical VBR, Graft Packing Block
00843511100414Omnia Medical VBR, Trial
00843511100407Omnia Medical VBR, Inserter
00843511100391Omnia Medical VBR, 14mm X 14.5mm X 7.5 Deg End Cap
00843511100384Omnia Medical VBR, 14mm X 14.5mm X 5 Deg End Cap
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