FDA.reportPublic FDA data

Cochlear™ Nucleus® Contour Advance® Depth Gauge

Primary DI
09321502019439
Brand
Cochlear™ Nucleus® Contour Advance® Depth Gauge
Company
COCHLEAR LIMITED
Model
Z179994
Catalog number
Z179994
Device description
electrode depth gauge
Published
2020-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL
MCMImplant, cochlear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1
MCMImplant, CochlearUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970051048

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970051048NUCLEUS 24 COCHLEAR IMPLANT SYSTEMCochlear Americas1998-06-25MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502019439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502019439093215020194399321502019439

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity75 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
750551194
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09321502046459CochlearP1624218P16242182020-01-03
09321502046466CochlearP1624188P16241882020-01-03
09321502046473CochlearP1624189P16241892020-01-03
09321502046480CochlearP1624190P16241902020-01-03
09321502046497CochlearP1624191P16241912020-01-03
09321502039864Nucleus® 7 Processing UnitCP1000Z5445592017-07-07
09321502014564Cochlear® Nucleus® CI512 cochlear ImplantCI512Z2090512014-09-24
09321502063692Cochlear™ Personalisation CoverP1840531P18405312022-11-30
09321502063715Cochlear™ Personalisation CoverP1840591P18405912022-11-30
09321502066815Cochlear™ Microphone CoverP1878176P18781762022-11-29
09321502066822Cochlear™ Microphone CoverP1878194P18781942022-11-29
09321502066839Cochlear™ Microphone CoverP1878177P18781772022-11-29
09321502066846Cochlear™ Microphone CoverP1878196P18781962022-11-29
09321502066853Cochlear™ Microphone CoverP1878199P18781992022-11-29
09321502066860Cochlear™ Microphone CoverP1878197P18781972022-11-29
09321502006910NucleusZ33012Z330122014-09-24
09321502053662Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Black, 6cm (2 1/2"")"P17496472025-07-07
09321502053679Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Brown, 6cm (2 1/2"")"P17496482025-07-07
09321502053686Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Grey, 6cm (2 1/2"")"P17496492025-07-07
09321502053693Cochlear™ Nucleus® 8 Nexa™ Slimline™ Coil"Sand, 6cm (2 1/2"")"P17496502025-07-07

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