FDA.reportPublic FDA data

Bone bed indicator

Primary DI
09321502032827
Brand
Bone bed indicator
Company
Cochlear Bone Anchored Solutions AB
Model
95180
Catalog number
95180
Device description
N/A
Published
2017-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL
LXBHearing aid, bone conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1
LXBHearing Aid, Bone ConductionEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955713000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502032827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502032827093215020328279321502032827

GMDN Terms#

Term, Definition table
TermDefinition
General external orthopaedic fixation system implantation kit, reusableA collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
559784736
Device count
1
Premarket exempt
true
Lot or batch
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

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Primary DI, Brand, Company table
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