AccessGUDID - DEVICE: Mi1210 SYNCHRONY ST +FLEX26 (09008737366193)

GUDID

Device Identifier (DI) Information

Brand Name: Mi1210 SYNCHRONY ST +FLEX26
Version or Model: 36619
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 36631
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737366193
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?
47373	Cochlear implant system electrode array assembly	The implantable portion of a cochlear implant system [cochlear implant (CI)] that typically consists of an electrically-powered electrode array surgically implanted in one cochlea, and a receiver-stimulator implanted in the skull near the ear and connected to the electrode array; it does not elute a drug. Electrical signals are transmitted from the external portion of the device to the receiver-stimulator and ultimately to the cochlea, via the electrode array, for the partial restoration of auditory sensation in a severely/profoundly deaf person. Dedicated implantation instruments may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MCM	Implant, Cochlear

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000025	106
P000025	122

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
Handling Environment Temperature: between -20 and 55 Degrees Celsius
Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit
Special Storage Condition, Specify: The sterilized implant may only be stored in this sterile packaging inside the Implant 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: f0f009d5-a059-4a12-9369-30e56fe8a1cf
Public Version Date: May 19, 2022
Public Version Number: 3
DI Record Publish Date: August 16, 2019