AccessGUDID - DEVICE: Clinician's Programming Interface (07630016809705)

GUDID

Device Identifier (DI) Information

Brand Name: Clinician's Programming Interface
Version or Model: AB-6500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Advanced Bionics, LLC

Primary DI Number: 07630016809705
Issuing Agency: GS1
Commercial Distribution End Date: March 20, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 803906382 *Terms of Use

Device Description: No description.

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):	No
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?
58794	Hearing implant implantable-component tester, postoperative	A portable electronic device designed to perform an integrity test on the implantable portion of a hearing implant [e.g., cochlear implant (CI)] system in situ postoperatively (e.g., during routine checks); the test is intended to provide objective data on implant function and aid in the assessment of implant failure/fault modes. It typically consists of hardware (e.g., biological signal amplifier, sound processor, coils, sign cables, magnets, leads) and software, and possibly includes consumables (e.g., skin electrodes/gel, swabs/wipes, tapes), to provide implant stimulation to the patient and acquire skin surface potential waveforms from the patient. 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 [?]
P960058	031

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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bdcc9a17-0908-4f21-b460-8fbf445b8307
Public Version Date: March 25, 2024
Public Version Number: 5
DI Record Publish Date: October 08, 2015