FDA.report

Cochlear™ Slim Modiolar Electrode Sheath

Primary DI
09321502043564
Brand
Cochlear™ Slim Modiolar Electrode Sheath
Company
COCHLEAR LIMITED
Model
P1291522
Catalog number
P1291522
Device description
N/A
Published
2019-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09321502043564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09321502043564093215020435649321502043564

GMDN Terms

TermDefinition
Cochlear electrode array introducer, single-useA sterile, hand-held manual surgical instrument designed to aid insertion of an electrode array into the cochlea during implantation of a cochlear implant. It is typically a thin shaft onto which the electrode is distally mounted and then advanced into the cochlea by means of a manually-operated sliding mechanism. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)523-5798customer@cochlear.com

Regulatory Flags

DUNS number
750551194
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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09321502006910NucleusZ33012Z330122014-09-24
09321502053082Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Straight electrodeCI1022Z3342042025-07-07
09321502053099Cochlear™ Nucleus® Nexa™ cochlear implant with Slim Modiolar electrodeCI1032P14349292025-07-07
09321502053105Cochlear™ Nucleus® Nexa™ cochlear implant with Slim 20 electrodeCI1024P15496742025-07-07
09321502053662Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilBlack, 6cm (2 1/2")P17496472025-07-07
09321502053679Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilBrown, 6cm (2 1/2")P17496482025-07-07
09321502053686Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilGrey, 6cm (2 1/2")P17496492025-07-07
09321502053693Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilSand, 6cm (2 1/2")P17496502025-07-07
09321502053709Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilWhite, 6cm (2 1/2")P17496512025-07-07
09321502053716Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilSilver, 6cm (2 1/2")P17496522025-07-07
09321502053785Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilBlack, 8cm (3")P17496592025-07-07
09321502053792Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilBrown, 8cm (3")P17496602025-07-07
09321502053808Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilGrey, 8cm (3")P17496612025-07-07
09321502053815Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilSand, 8cm (3")P17496622025-07-07
09321502053822Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilWhite, 8cm (3")P17496632025-07-07
09321502053839Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilSilver, 8cm (3")P17496642025-07-07
09321502053969Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilBlack, 11cm (4")P17496772025-07-07
09321502053976Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilBrown, 11cm (4")P17496782025-07-07
09321502053983Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilGrey, 11cm (4")P17496792025-07-07
09321502053990Cochlear™ Nucleus® 8 Nexa™ Slimline™ CoilSand, 11cm (4")P17496802025-07-07

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