FDA UDI
Not in Commercial Distribution
🇺🇸 United States
egger
DI: EGOL206171
·
Model: A/soft S 50
·
Egger Otoplastik + Labortechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
8
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Basic Information
- Brand Name
- egger
- Primary DI
- EGOL206171
- Version / Model
- A/soft S 50
- Company Name
- Egger Otoplastik + Labortechnik GmbH
- Labeler DUNS
- 328465042
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2022-08-31
- Public Version
- 2
- Public Version Date
- 2024-09-27
- Public Version Status
- Update
- Public Device Record Key
- 216e53c9-45b5-4773-8990-826d14889929
- Distribution End Date
- 2024-05-26
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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ESD | Hearing Aid, Air Conduction | Ear, Nose, Throat | 874.3300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44974 | Earmould impression material | A rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | EGOL206190 | HIBCC | ||||
| Primary | EGOL206171 | HIBCC |