AccessGUDID - DEVICE: Cochlear™ CP1110S Surgical Coil (09321502054348)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear™ CP1110S Surgical Coil
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1749715
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502054348
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: Hearing Implant Accessory

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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?
64984	Cochlear implant intraoperative electrophysiological transceiver	A noninvasive, electrically-powered device designed to wirelessly receive electrophysiological data (e.g., impedance, neural response) from the electrode array assembly of a cochlear implant system during implantation, and wirelessly transmit the data in real-time to an off-the-shelf computer/tablet with appropriate software installed. The data is intended for intraoperative analysis of the placement and in situ function of the implanted electrode array.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970051	225

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 7da2dc28-bffc-4b2b-b8e9-754e6aac5114
Public Version Date: July 15, 2025
Public Version Number: 1
DI Record Publish Date: July 07, 2025

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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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