Omnia Medical TiBrid™-SA

GUDID 00843511112868

TiBrid™-SA PLATE, 32mm, L5-S1

OMNIA MEDICAL, LLC

Spinal fixation plate, non-bioabsorbable
Primary Device ID00843511112868
NIH Device Record Keyaf2c45e2-0fb7-4c29-95b8-f62b063e7d93
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnia Medical TiBrid™-SA
Version Model Number17-0A-PLT6
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

Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter
Height32 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511112868 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

Moist Heat or Steam Sterilization

[00843511112868]

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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