AccessGUDID - DEVICE: MRI Antenna Coil Cover (00840094456051)

GUDID

Device Identifier (DI) Information

Brand Name: MRI Antenna Coil Cover
Version or Model: CI-7521
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Advanced Bionics, LLC

Primary DI Number: 00840094456051
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 803906382 *Terms of Use
Previous DI: 07630016849503

Device Description: No description.

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):	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?
63638	Cochlear implant implantable magnet MRI shield	A non-sterile device intended to secure the implantable magnet in the cochlear implant system in the presence of the magnetic field produced by a magnetic resonance imaging (MRI) system, to prevent displacement of the magnet during an MRI procedure. It is intended to be placed externally on the head of the patient directly over the implant, typically using a bandage(s) and/or tape(s); it is made of synthetic polymer materials (e.g., polycarbonate, polyester). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P960058	117

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: d6e964bc-9ed6-4b96-83ab-30549b52f54f
Public Version Date: January 23, 2023
Public Version Number: 1
DI Record Publish Date: January 13, 2023