FDA.reportPublic FDA data

Counter Torque Wrench

Primary DI
09321502045056
Brand
Counter Torque Wrench
Company
Cochlear Bone Anchored Solutions AB
Model
P1582231
Catalog number
P1582231
Published
2023-05-15
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
K955713000NOBELPHARMA BONE ANCHORED HEARING AIDNobelpharma USA, Inc.1996-08-09LXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502045056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502045056093215020450569321502045056

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
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
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
09321502020664Baha90095900952017-06-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04250676750822Lucae cerumen hookSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750839Lucae cerumen hookSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
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04250676750907Billeau ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750914Billeau ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750921Snellen ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
04250676750938Snellen ear loopSpiggle & Theis Medizintechnik GmbHLRC2026-10-28
B382SD67371410Surgical DirectSurgical Direct, Inc.LRC2026-10-28
B382SD9114681000Surgical DirectSurgical Direct, Inc.LRC2026-10-28
00190776423070MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435813MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435820MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435837MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435844MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435851MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435868MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436735MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436742MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776436759MillenniumAvalign Technologies, Inc.LRC2026-10-21
00190776435417MillenniumAvalign Technologies, Inc.LRC2026-10-19
00190776434946MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434977MillenniumAvalign Technologies, Inc.LRC2026-10-14
00190776434618MillenniumAvalign Technologies, Inc.LRC2026-10-09
00198506095795ELMED INCORPORATEDELMED INCORPORATEDLRC2026-10-09
00190776433529MillenniumAvalign Technologies, Inc.LRC2026-10-06
00192896123854Gum ScissorsSONTEC INSTRUMENTS, INC.LRC2026-10-06
00190776433093MillenniumAvalign Technologies, Inc.LRC2026-10-01