AccessGUDID - DEVICE: FREEDOM LAPEL MICROPHONE (LAP1) (09321502013246)

GUDID

Device Identifier (DI) Information

Brand Name: FREEDOM LAPEL MICROPHONE (LAP1)
Version or Model: Z60831
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Z60831
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502013246
Issuing Agency: GS1
Commercial Distribution End Date: November 14, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: FREEDOM LAPEL MICROPHONE (LAP1)

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":	Yes
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?
61245	Cochlear implant/auditory brainstem implant peripheral connector	A device designed to be used with a cochlear implant (CI) or auditory brainstem implant system to connect the sound processor to power options (e.g., battery pack) and/or to enable connections to external devices that may be used as peripherals to the implant system; the connected devices are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	IMPLANT, COCHLEAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970051	028

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: 90872aae-b5f5-48b8-9629-f4d34507d4dc
Public Version Date: July 28, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2014