Accufuse Cervical System

Primary DI
00810016800804
Brand
Accufuse Cervical System
Company
ABSOLUTE ADVANTAGE MEDICAL, LLC
Model
10-02
Catalog number
10-02
Device description
Bone Awl, Open
Published
2019-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00810016800804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016800804008100168008048100168008040810016800804

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
056248579
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810016801078Accufuse Cervical System10-1310-132019-04-24
00810016800002Accufuse Cervical System1P7C51P7C52019-04-24
00810016800019Accufuse Cervical System1P9C71P9C72019-04-24
00810016800026Accufuse Cervical System1P8C61P8C62019-04-24
00810016800033Accufuse Cervical System1P10C81P10C82019-04-24
00810016800040Accufuse Cervical System1P11C91P11C92019-04-24
00810016800057Accufuse Cervical System1P12C101P12C102019-04-24
00810016800064Accufuse Cervical System1P13C111P13C112019-04-24
00810016800071Accufuse Cervical System1P14C121P14C122019-04-24
00810016800088Accufuse Cervical System2P232P232019-04-24
00810016800095Accufuse Cervical System2P262P262019-04-24
00810016800101Accufuse Cervical System2P292P292019-04-24
00810016800118Accufuse Cervical System2P322P322019-04-24
00810016800125Accufuse Cervical System2P352P352019-04-24
00810016800132Accufuse Cervical System2P382P382019-04-24
00810016800149Accufuse Cervical System2P412P412019-04-24
00810016800156Accufuse Cervical System2P442P442019-04-24
00810016800163Accufuse Cervical System1P7P81P7P82019-04-24
00810016800170Accufuse Cervical System1P9P101P9P102019-04-24
00810016800187Accufuse Cervical System1P11P121P11P122019-04-24

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