FDA.reportPublic FDA data

Omnia Medical Coupler-C

Primary DI
00843511113421
Brand
Omnia Medical Coupler-C
Company
OMNIA MEDICAL, LLC
Model
15-3C-ASMS-72
Catalog number
15-3C-ASMS-72
Device description
STATIC CERVICAL PLATE ASSEMBLY, 3 LEVEL, 72mm
Published
2024-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843511113421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511113421008435111134218435111134210843511113421

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length72Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3044134851customerservice@omniamedical.com

Regulatory Flags#

DUNS number
079467378
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843511128388Omnia Medical TiBrid™- A/SA 17-5A-BL0617-5A-BL062026-05-11
00843511128395Omnia Medical TiBrid™- A/SA 17-5A-BL082026-05-11
00843511128401Omnia Medical TiBrid™- A/SA 17-5A-BL102026-05-11
00843511128418Omnia Medical TiBrid™- A/SA 17-5A-BL122026-05-11
00843511128425Omnia Medical TiBrid™- A/SA 17-5A-BL142026-05-11
00843511128432Omnia Medical TiBrid™- A/SA 17-5A-BL162026-05-11
00843511128463Omnia Medical TiBrid™- A/SA 17-5A-AWL1-B2026-05-11
00843511128494Omnia Medical TiBrid™-C07-5C-LTDE2026-05-11
00843511128500Omnia Medical Instruments99-5A-CL132026-05-11
00843511128517Omnia Medical Instruments99-5A-CL202026-05-11
00843511128548Omnia Medical Golden Spike OM-TLS4015-T2026-05-11
00843511128555Omnia Medical Golden Spike OM-TLS4016-T2026-05-11
00843511128562Omnia Medical Golden Spike OM-TLS4017-T2026-05-11
00843511128579Omnia Medical Golden Spike OM-TLS4018-T2026-05-11
00843511128586Omnia Medical Golden Spike OM-TLS4019-T2026-05-11
00843511128593Omnia Medical Golden Spike OM-TLS4020-T2026-05-11
00843511128609Omnia Medical Golden Spike OM-TLS4021-T2026-05-11
00843511128616Omnia Medical Golden Spike OM-TLS4022-T2026-05-11
00843511128623Omnia Medical Golden Spike OM-TLS4023-T2026-05-11
00843511128630Omnia Medical Golden Spike OM-TLS4024-T2026-05-11

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Primary DI, Brand, Company table
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