FDA UDI
In Commercial Distribution
🇺🇸 United States
Verifit Adapter
DI: 09008737415808
·
Model: 41580
·
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Verifit Adapter
- Primary DI
- 09008737415808
- Version / Model
- 41580
- 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
- 2025-11-17
- Public Version
- 2
- Public Version Date
- 2026-03-27
- Public Version Status
- Update
- Public Device Record Key
- b6e6aca4-0e24-4ffe-95b5-0d2a49daae79
Device Description
Adapter
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LXB | Hearing Aid, Bone Conduction | Ear, Nose, Throat | 874.3302 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67659 | Hearing aid/artificial mastoid adaptor | A device designed to facilitate the connection between a bone vibrator (transducer) and an artificial mastoid [also known as a mechanical coupler] during verification of a bone-conduction hearing aid vibrator/transducer. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09008737415808 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20.2 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity