AccessGUDID - DEVICE: Cochlear™ Sterile Replacement Magnet (09321502046534)

GUDID

Device Identifier (DI) Information

Brand Name: Cochlear™ Sterile Replacement Magnet
Version or Model: P1620873
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1620873
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502046534
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *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):	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?
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
PFO	Active implantable bone conduction hearing system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191921	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 9507f0c2-24df-4978-84f8-0bd629742791
Public Version Date: March 17, 2021
Public Version Number: 1
DI Record Publish Date: March 09, 2021