FDA.reportPublic FDA data

Abutment replica

Primary DI
09321502016230
Brand
Abutment replica
Company
Cochlear Bone Anchored Solutions AB
Model
90374
Catalog number
90374
Device description
Laboratory component for prior generation Vistafix
Published
2020-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZEPROSTHESIS, NOSE, INTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZEProsthesis, Nose, InternalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502016230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502016230093215020162309321502016230

GMDN Terms#

Term, Definition table
TermDefinition
General external orthopaedic fixation system implantation kit, single-useA collection of non-sterile, manual surgical instruments intended to be used for the placement of an external orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes various instruments [e.g., retractors, rods, clamps, drills, pins/screws, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of external orthopaedic fixation system (i.e., non-dedicated); it does not include any implantable devices. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-5798customer@cochlear.com

Regulatory Flags#

DUNS number
559784736
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09321502019613Baha92140921402015-10-09
09321502019620Baha92141921412015-10-09
09321502025157Baha93339933392017-06-07
09321502026505Baha93363933632015-10-09
09321502045018Bone Bed Indicator 14mmP1578046P15780462023-05-15
09321502045025Baha IndicatorP1582203P15822032023-05-15
09321502045032Abutment InserterP1582229P15822292023-05-15
09321502045049Implant InserterP1582230P15822302023-05-15
09321502045056Counter Torque WrenchP1582231P15822312023-05-15
09321502046312Raspatorium/ProbeP1593725P15937252023-05-15
09321502021746Counter torque wrench for Vistafix® VXA30093183931832017-06-07
09321502027090Soft tissue gauge 6 mm95070950702017-06-07
09321502036351BahaP806653P8066532017-06-07
09321502036368BahaP806693P8066932017-06-07
09321502040105Baha90238902382017-06-07
09321502015912Baha90623906232017-07-03
09321502016032Baha90627906272017-07-03
09321502020657Baha90068900682017-07-03
09321502040051Baha90625906252017-07-03
09321502040068Baha90629906292017-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09321502015615BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502020732BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502021760BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502021777BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502034579BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040075BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040082BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040099BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
00841036204181HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-15
00841036203955HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203962HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203979HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203986HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203849HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-09
00841036203856HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-09
00841036203689HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203771HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203788HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203795HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203801HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203580HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203597HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203603HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203610HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203627HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203634HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203351HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203368HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203375HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203382HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04