Omnia Medical TiBrid™-A

GUDID 00843511110185

TiBrid™-A RASP, 36x27x16mm, 12°

OMNIA MEDICAL, LLC

Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID00843511110185
NIH Device Record Keybcfc05b1-39f4-459c-b6bd-c93e84b0d23a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnia Medical TiBrid™-A
Version Model Number14-5A-RA362716-12
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
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com

Device Dimensions

Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree
Width36 Millimeter
Length27 Millimeter
Height16 Millimeter
Angle12 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511110185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

[00843511110185]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-31
Device Publish Date2024-01-23

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

00843511109912TiBrid™-A RASP, 32x25x10mm, 8°
00843511109905TiBrid™-A RASP, 32x25x8mm, 8°
00843511111199TiBrid™-A TRIAL, 40x29x18mm, 20°
00843511111182TiBrid™-A TRIAL, 40x29x16mm, 20°
00843511111175TiBrid™-A TRIAL, 40x29x14mm, 20°
00843511111168TiBrid™-A TRIAL, 40x29x12mm, 20°
00843511111151TiBrid™-A TRIAL, 36x27x18mm, 20°
00843511111144TiBrid™-A TRIAL, 36x27x16mm, 20°
00843511111137TiBrid™-A TRIAL, 36x27x14mm, 20°
00843511111120TiBrid™-A TRIAL, 36x27x12mm, 20°
00843511111113TiBrid™-A TRIAL, 32x25x18mm, 20°
00843511111106TiBrid™-A TRIAL, 32x25x16mm, 20°
00843511111090TiBrid™-A TRIAL, 32x25x14mm, 20°
00843511111083TiBrid™-A TRIAL, 32x25x12mm, 20°
00843511111076TiBrid™-A TRIAL, 32x25x10mm, 20°
00843511111069TiBrid™-A TRIAL, 40x29x18mm, 16°
00843511111052TiBrid™-A TRIAL, 40x29x16mm, 16°
00843511111045TiBrid™-A TRIAL, 40x29x14mm, 16°
00843511111038TiBrid™-A TRIAL, 40x29x12mm, 16°
00843511111021TiBrid™-A TRIAL, 40x29x10mm, 16°
00843511111014TiBrid™-A TRIAL, 36x27x18mm, 16°
00843511111007TiBrid™-A TRIAL, 36x27x16mm, 16°
00843511110994TiBrid™-A TRIAL, 36x27x14mm, 16°
00843511110987TiBrid™-A TRIAL, 36x27x12mm, 16°
00843511110970TiBrid™-A TRIAL, 36x27x10mm, 16°
00843511110963TiBrid™-A TRIAL, 32x25x18mm, 16°
00843511110956TiBrid™-A TRIAL, 32x25x16mm, 16°
00843511110949TiBrid™-A TRIAL, 32x25x14mm, 16°
00843511110932TiBrid™-A TRIAL, 32x25x12mm, 16°
00843511110925TiBrid™-A TRIAL, 32x25x10mm, 16°
00843511110918TiBrid™-A TRIAL, 32x25x8mm, 16°
00843511110901TiBrid™-A TRIAL, 40x29x18mm, 12°
00843511110895TiBrid™-A TRIAL, 40x29x16mm, 12°
00843511110888TiBrid™-A TRIAL, 40x29x14mm, 12°
00843511110871TiBrid™-A TRIAL, 40x29x12mm, 12°
00843511110864TiBrid™-A TRIAL, 40x29x10mm, 12°
00843511110857TiBrid™-A TRIAL, 40x29x8mm, 12°
00843511110840TiBrid™-A TRIAL, 36x27x18mm, 12°
00843511110833TiBrid™-A TRIAL, 36x27x16mm, 12°
00843511110826TiBrid™-A TRIAL, 36x27x14mm, 12°
00843511110819TiBrid™-A TRIAL, 36x27x12mm, 12°
00843511110802TiBrid™-A TRIAL, 36x27x10mm, 12°
00843511110796TiBrid™-A TRIAL, 36x27x8mm, 12°
00843511110789TiBrid™-A TRIAL, 32x25x18mm, 12°
00843511110772TiBrid™-A TRIAL, 32x25x16mm, 12°
00843511110765TiBrid™-A TRIAL, 32x25x14mm, 12°
00843511110758TiBrid™-A TRIAL, 32x25x12mm, 12°
00843511110741TiBrid™-A TRIAL, 32x25x10mm, 12°
00843511110734TiBrid™-A TRIAL, 32x25x8mm, 12°
00843511110727TiBrid™-A TRIAL, 40x29x18mm, 8°
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