Omnia Medical TiBrid™-SA

GUDID 00843511111847

TiBrid™-SA PLATE, 34mm, L1-L5

OMNIA MEDICAL, LLC

Spinal fixation plate, non-bioabsorbable
Primary Device ID00843511111847
NIH Device Record Key75f03e80-5455-417d-bc5c-3d6739cc6e02
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnia Medical TiBrid™-SA
Version Model Number17-0A-PLT2
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
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com

Device Dimensions

Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter
Height34 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511111847 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


[00843511111847]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-20
Device Publish Date2024-06-12

On-Brand Devices [Omnia Medical TiBrid™-SA]

00843511128128TiBrid™ SA Plastic Sleeve
00843511128111TiBrid™ SA Self Drilling Variable Tack, 6.0 x 25mm
00843511128104TiBrid™ SA Self Drilling Variable Tack, 6.0 x 20mm
00843511128098TiBrid™ SA Self Drilling Variable Tack, 6.0 x 15mm
00843511112899TiBrid™-SA PLATE, 38mm, L5-S1
00843511112882TiBrid™-SA PLATE, 36mm, L5-S1
00843511112875TiBrid™-SA PLATE, 34mm, L5-S1
00843511112868TiBrid™-SA PLATE, 32mm, L5-S1
00843511112851TiBrid™-SA PLATE, 30mm, L5-S1
00843511111861TiBrid™-SA PLATE, 38mm, L1-L5
00843511111854TiBrid™-SA PLATE, 36mm, L1-L5
00843511111847TiBrid™-SA PLATE, 34mm, L1-L5
00843511111830TiBrid™-SA PLATE, 32mm, L1-L5
00843511111823TiBrid™-SA PLATE, 30mm, L1-L5

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