FDA UDI
In Commercial Distribution
🇺🇸 United States
SAMBA 2 GO w/o manuals
DI: 09008737532925
·
Model: 53292
·
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SAMBA 2 GO w/o manuals
- Primary DI
- 09008737532925
- Version / Model
- 53292
- Company Name
- Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Labeler DUNS
- 300764032
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-16
- Public Version
- 1
- Public Version Date
- 2022-11-24
- Public Version Status
- New
- Public Device Record Key
- 163dc2fb-bf76-46ff-9f1d-f512be017c6c
Device Description
Audio Processor Streaming Device
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| PFO | Active Implantable Bone Conduction Hearing System | Ear, Nose, Throat | 874.3340 | 2 |
| MPV | Implant, Hearing, Active, Middle Ear, Partially Implanted | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60259 | Hearing aid/implant system functionality-enhancing device | An electrically-powered device designed to use a wired or wireless connection to a hearing aid (e.g., bone-conduction) or hearing implant system (e.g., cochlear, bone-conduction, partially-implantable middle ear) sound processor to enhance its functionality and/or sound quality [e.g., enable transmission from a multimedia device (e.g., computer, phone, mp3 player) to the hearing device]. It is typically a transmitter/receiver in the form of a microphone, an audio jack, room loop receiver/booster, small attachment and/or a wireless connection receiver. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09008737532925 | GS1 |
Customer Contacts
- Phone
- 1-888-633-3524
- [email protected]