AccessGUDID - DEVICE: Esteem® Intraoperative System Analyzer (00812282020160)

GUDID

Device Identifier (DI) Information

Brand Name: Esteem® Intraoperative System Analyzer
Version or Model: 3001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 903001-003
Company Name: Envoy Medical Corporation

Primary DI Number: 00812282020160
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 939725313 *Terms of Use

Device Description: Intraoperative System Analyzer (ISA), Software and Computer

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
58991	Fully-implantable middle ear implant system	An implanted assembly of sterile devices intended to compensate for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via an external device. It consists of a capsule, containing the battery and processor unit, and an attached microphone and transducer that are fully implanted. The microphone receives sound waves that are converted into electrical signals which drive the transducer to vibrate the middle ear bones, stimulating the auditory pathway. A middle ear implant (MEI) is typically used to treat sensorineural hearing loss (SNHL) or hearing impairment due to middle and/or outer ear obstructive pathologies.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OAF	Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P090018	000
P090018	004
P090018	024

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 3f890af0-04f4-431a-b5e9-d4a2af5f2520
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2014