FDA UDI
In Commercial Distribution
🇺🇸 United States
Esteem® Ear Insert Assembly
DI: 00812282020351
·
Model: 1200
·
Envoy Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Esteem® Ear Insert Assembly
- Primary DI
- 00812282020351
- Version / Model
- 1200
- Catalog Number
- 901200-013
- Company Name
- Envoy Medical Corporation
- Labeler DUNS
- 939725313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fe8b935a-73c3-4689-9b0d-7bd6db739acf
Device Description
Sterile Ear Insert Assembly, Large (17.8mm Foam)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAF | Implant, Hearing, Active, Middle Ear, Totally Implanted | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812282020351 | GS1 |
Customer Contacts
- Phone
- 6513618000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P090018 | 005 |
| P090018 | 018 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 17.8 | Millimeter |