FDA UDI
In Commercial Distribution
🇺🇸 United States
M Acoustic Earhook
DI: 00840094447097
·
Model: CI-5851-010
·
Advanced Bionics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- M Acoustic Earhook
- Primary DI
- 00840094447097
- Version / Model
- CI-5851-010
- Company Name
- Advanced Bionics, LLC
- Labeler DUNS
- 803906382
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-13
- Public Version
- 1
- Public Version Date
- 2023-01-23
- Public Version Status
- New
- Public Device Record Key
- 252c320c-2023-43a6-addc-48ebb0d8ff83
Device Description
Left 3
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MCM | Implant, cochlear | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62901 | Cochlear implant/auditory brainstem implant sound processor speaker | A small device designed to be attached to the sound processor of a cochlear implant or auditory brainstem implant system and extended into the external ear canal to function as a speaker providing amplified acoustic low-frequency sound to the eardrum, as a conjunct to the electrical input to the implant. It is intended for patients with improvable low-frequency hearing and is typically made of synthetic polymer materials with metallic components. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840094447097 | GS1 | ||||
| Previous | 07630016880872 | GS1 |
Customer Contacts
- Phone
- +1(661)362-1400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P960058 | 149 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity