AccessGUDID - DEVICE: HiRes™ Ultra 3D Replacement Magnet (07630016854163)

GUDID

Device Identifier (DI) Information

Brand Name: HiRes™ Ultra 3D Replacement Magnet
Version or Model: CI-1419
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Advanced Bionics AG

Primary DI Number: 07630016854163
Issuing Agency: GS1
Commercial Distribution End Date: March 14, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 485262658 *Terms of Use

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?
62601	Cochlear implant implantable magnet	A small, sterile, magnetic device intended to be implanted subcutaneously within the implantable component of a cochlear implant system (CIS) and to couple with a magnet in the CIS external component, to hold implantable and external components in place. It is typically a magnetized metal disc contained within a non-reactive metal (e.g., titanium) case.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, Cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P960058	129

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: b7042269-ef3e-4922-9d45-76440eb79e21
Public Version Date: March 15, 2024
Public Version Number: 4
DI Record Publish Date: August 31, 2018