FDA.report

Omnia Medical Coupler-C

Primary DI
00843511113575
Brand
Omnia Medical Coupler-C
Company
OMNIA MEDICAL, LLC
Model
15-5C-DRL2
Catalog number
15-5C-DRL2
Device description
CERVICAL DRILL, Ø4.5 X 8 MM
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
00843511113575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511113575008435111135758435111135750843511113575

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes

TypeValueUnit
Length8Millimeter
Outer Diameter4.5Millimeter

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

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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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