FDA.report

OSI200 Implant template

Primary DI
09321502043700
Brand
OSI200 Implant template
Company
COCHLEAR LIMITED
Model
P1291019
Catalog number
P1291019
Device description
N/A
Published
2019-11-23
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
09321502043700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09321502043700093215020437009321502043700

GMDN Terms

TermDefinition
Surgical implant template, single-useA 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 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
false
Sterilization required before use
false

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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
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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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