AccessGUDID - DEVICE: Cochlear (09321502046152)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear
Version or Model: P1170466
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1170466
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502046152
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: Cochlear Osia OSI200 Implant

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64989	Bone-conduction hearing implant system vibrator assembly	An electrically-powered, implantable device that typically consists of a radio-frequency (RF) antenna typically in the form of a coil, decoder, or vibrator coupled to the temporal bone, and a magnet. The antenna and decoder receive radio waves from the system’s external component and convert the signals back to audio frequencies, which are sent to the vibrator for the transmission of vibrations to the bone to activate the auditory pathway. The magnet is intended to couple with the system’s external component for positioning/stabilization of the system.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PFO	Active implantable bone conduction hearing system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191921	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f8a5b227-2d0a-4d11-a882-972df4f8639d
Public Version Date: March 07, 2025
Public Version Number: 2
DI Record Publish Date: November 23, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)523-5798
Email: customer@cochlear.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES