FDA.reportPublic FDA data

Baha

Primary DI
09321502021074
Brand
Baha
Company
Cochlear Bone Anchored Solutions AB
Model
04032600
Catalog number
04032600
Device description
Motor protective cover
Published
2017-07-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502021074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502021074093215020210749321502021074

GMDN Terms#

Term, Definition table
TermDefinition
Bone-conduction hearing implant system implantation toolA hand-held manual surgical instrument intended to assist with the implantation of the implantable component(s) of a bone-conduction hearing implant system (typically the magnet and/or vibration transmitter) into the temporal bone. It is typically in the form of a drill or pin; it may also have a component intended to sweep/scan (non-powered) the cranial bone surface to determine whether there is sufficient depth to place the implantable magnet. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
559784736
Device count
1

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

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