AccessGUDID - DEVICE: ANTS Electrode (09008737371371)

GUDID

Device Identifier (DI) Information

Brand Name: ANTS Electrode
Version or Model: 37137
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Primary DI Number: 09008737371371
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300764032 *Terms of Use

Device Description: Diagnostic Electrode

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
64802	Cochlear nerve function operative test electrode	An invasive, hand-held, thin instrument (probe) with a distal electrode intended for preoperative and/or intraoperative delivery of electrical stimulation to the cochlear (auditory) nerve to assess nerve function prior to implantation of a cochlear implant (CI). It may be used during open surgery or via transtympanic approach and conducts electrical current via connection to an external electrical pulse generator; it is used in conjunction with an evoked auditory brainstem response (eABR) recording system. 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 [?]
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: f46c3119-f8c3-4766-9183-665b4159fe44
Public Version Date: November 01, 2024
Public Version Number: 1
DI Record Publish Date: October 24, 2024