AccessGUDID - DEVICE: Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet (09008737415433)

GUDID

Device Identifier (DI) Information

Brand Name: Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet
Version or Model: 41543
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 41547
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737415433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Cochlear Implant

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?
35643	Cochlear implant system	A battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a severely/profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Dedicated implantation instruments may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PGQ	Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000025	127

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
Special Storage Condition, Specify: Store the sterilized contents in this box at room temperature until the stated expiry date.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c36dc149-b821-4b75-9c4e-dec61fb9daeb
Public Version Date: October 23, 2024
Public Version Number: 1
DI Record Publish Date: October 15, 2024