FDA.report

Omnia Medical Coupler-C

Primary DI
00843511113636
Brand
Omnia Medical Coupler-C
Company
OMNIA MEDICAL, LLC
Model
15-5C-PBD1
Catalog number
15-5C-PBD1
Device description
CERVICAL PLATE BENDER
Published
2024-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00843511113636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511113636008435111136368435111136360843511113636

GMDN Terms

TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
3044134851customerservice@omniamedical.com

Regulatory Flags

DUNS number
079467378
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00843511111205Omnia Medical TiBrid™-A 14-5A-IMPT14-5A-IMPT2024-02-22
00843511113735Omnia Medical PSiFDNA11-0P-0001-2811-0P-0001-282025-09-22
00843511113742Omnia Medical PSiFDNA11-0P-0001-3811-0P-0001-382025-09-22
00843511113759Omnia Medical PSiFDNA11-0P-0001-4411-0P-0001-442025-09-22
00843511113766Omnia Medical PSiFDNA11-0P-000211-0P-00022025-09-22
00843511122768Omnia Medical PSiFDNA11-5P-DRV1-SS11-5P-DRV1-SS2025-09-22
00843511122775Omnia Medical PSiFDNA11-5P-IMP1-SS11-5P-IMP1-SS2025-09-22
00843511122799Omnia Medical PSiFDNA11-5P-DRL1-SS11-5P-DRL1-SS2025-09-22
00843511122805Omnia Medical PSiFDNA11-7P-TRY111-7P-TRY12025-09-22
00843511128227Omnia Medical PSiFDNA11-5P-STC1-SS11-5P-STC1-SS2025-09-22
00843511128142Omnia Medical Instruments 99-5U-STDB-F99-5U-STDB-F2025-07-15
00843511128258Omnia Medical Instruments99-5A-CPP199-5A-CPP12025-07-15
00843511128265Omnia Medical Instruments17-5A-INS1-S1008435111282652025-07-15
00843511128272Omnia Medical Instruments17-5A-INS1-S217-5A-INS1-S22025-07-15
00843511128296Omnia Medical Instruments17-5A-TAC117-5A-TAC12025-07-15
00843511128302Omnia Medical Instruments17-5A-TAC217-5A-TAC22025-07-15
00843511128319Omnia Medical Instruments17-5A-TAC317-5A-TAC32025-07-15
00843511128326TiBrid-SA17-5A-TACD17-5A-TACD2025-07-15
00843511128333TiBrid-SA17-5A-DRV1-LD17-5A-DRV1-LD2025-07-15
00843511128340Omnia Medical Instruments17-5A-IN9917-5A-IN992025-07-15

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