FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXUM
DI: M737M420R1
·
Model: M420R
·
Ototronix, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAXUM
- Primary DI
- M737M420R1
- Version / Model
- M420R
- Company Name
- Ototronix, LLC
- Labeler DUNS
- 833067478
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 34b04298-888f-4005-9af5-0057e3215302
Device Description
IMPLANT ASSEMBLY WITH IPC, SPLIT COIL, RIGHT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| MPV | Implant, Hearing, Active, Middle Ear, Partially Implanted | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30084 | Partially-implantable middle ear implant system | A battery-powered assembly of devices intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, to the middle ear. It primarily consists of an external microphone and a vibrator implanted in the middle ear that is coupled with an ossicle (middle ear bone) or the oval window. The microphone receives sound waves and converts them into electrical signals (radio waves) which are sent to the vibrator for the transmission of vibrations to the middle ear bones to activate 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 | M737M420R1 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P010023 | 000 |