Omnia Medical TiBrid™-SC 10-5C-RA16-07

GUDID 00843511105280

TiBrid™-SC RASP, 16.5x14.5x07mm

OMNIA MEDICAL, LLC

Bone file/rasp, manual, reusable
Primary Device ID00843511105280
NIH Device Record Key248ca8e7-dd5a-4bae-9f63-f0d3d40aa955
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnia Medical TiBrid™-SC
Version Model Number10-5C-RA16-07
Catalog Number10-5C-RA16-07
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 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
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

Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter
Width16.5 Millimeter
Length14.5 Millimeter
Height7 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511105280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

[00843511105280]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-16
Device Publish Date2024-02-08

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

00843511105037ANGLED PUNCH AWL, ASSEMBLY
00843511105020STRAIGHT AWL
00843511105334TiBrid™-SC RASP, 16.5x14.5x12mm
00843511105327TiBrid™-SC RASP, 16.5x14.5x11mm
00843511105310TiBrid™-SC RASP, 16.5x14.5x10mm
00843511105303TiBrid™-SC RASP, 16.5x14.5x09mm
00843511105297TiBrid™-SC RASP, 16.5x14.5x08mm
00843511105280TiBrid™-SC RASP, 16.5x14.5x07mm
00843511105273TiBrid™-SC RASP, 16.5x14.5x06mm
00843511105266TiBrid™-SC PLATE INSERTER, 18 X 15
00843511105259TiBrid™-SC PLATE INSERTER, 16.5 X 14.5
00843511105242TiBrid™-SC IMPACTOR
00843511105235SCREW COVER INSERTER
00843511105228ANGLED CERVICAL DRIVER
00843511105211ANGLED CERVICAL DRILL,Ø2.5mm
00843511105204ANGLED CERVICAL DRILL,Ø2.0mm
00843511105198SINGLE BARREL DRILL GUIDE
00843511104535TiBrid™-SC QUAD PLATE ASSEMBLY, 26mm
00843511104528TiBrid™-SC QUAD PLATE ASSEMBLY, 25mm
00843511104511TiBrid™-SC QUAD PLATE ASSEMBLY, 24mm
00843511104504TiBrid™-SC QUAD PLATE ASSEMBLY, 23mm
00843511104498TiBrid™-SC QUAD PLATE ASSEMBLY, 22mm
00843511104481TiBrid™-SC QUAD PLATE ASSEMBLY, 21mm
00843511104474TiBrid™-SC QUAD PLATE ASSEMBLY, 20mm
00843511104467TiBrid™-SC TRI PLATE ASSEMBLY, 26mm
00843511104450TiBrid™-SC TRI PLATE ASSEMBLY, 25mm
00843511104443TiBrid™-SC TRI PLATE ASSEMBLY, 24mm
00843511104436TiBrid™-SC TRI PLATE ASSEMBLY, 23mm
00843511104429TiBrid™-SC TRI PLATE ASSEMBLY, 22mm
00843511104412TiBrid™-SC TRI PLATE ASSEMBLY, 21mm
00843511104405TiBrid™-SC TRI PLATE ASSEMBLY, 20mm
00843511104399TiBrid™-SC DUO PLATE ASSEMBLY, 26mm
00843511104382TiBrid™-SC DUO PLATE ASSEMBLY, 25mm
00843511104375TiBrid™-SC DUO PLATE ASSEMBLY, 24mm
00843511104368TiBrid™-SC DUO PLATE ASSEMBLY, 23mm
00843511104351TiBrid™-SC DUO PLATE ASSEMBLY, 22mm
00843511104344TiBrid™-SC DUO PLATE ASSEMBLY, 21mm
00843511104337TiBrid™-SC DUO PLATE ASSEMBLY, 20mm
00843511104320TiBrid™-SC SCREW COVER
00843511105402TiBrid™-SC TRIAL, 16.5x14.5x12mm
00843511105396TiBrid™-SC TRIAL, 16.5x14.5x11mm
00843511105389TiBrid™-SC TRIAL, 16.5x14.5x10mm
00843511105372TiBrid™-SC TRIAL, 16.5x14.5x09mm
00843511105365TiBrid™-SC TRIAL, 16.5x14.5x08mm
00843511105358TiBrid™-SC TRIAL, 16.5x14.5x07mm
00843511105341TiBrid™-SC TRIAL, 16.5x14.5x06mm
00843511105044Interbody and Drill Guide Inserter
00843511105013SELF TAPPING VARIABLE SCREW, Ø4.5x18mm
00843511105006SELF TAPPING VARIABLE SCREW, Ø4.5x16mm
00843511104993SELF TAPPING VARIABLE SCREW, Ø4.5x14mm
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