FDA UDI
In Commercial Distribution
🇺🇸 United States
Sanibel Supply A/S
DI: 05711117099478
·
Model: Gold Eartip Electrode
·
Interacoustics A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Sanibel Supply A/S
- Primary DI
- 05711117099478
- Version / Model
- Gold Eartip Electrode
- Catalog Number
- 8500440
- Company Name
- Interacoustics A/S
- Labeler DUNS
- 306308354
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2023-11-27
- Public Version
- 1
- Public Version Date
- 2023-12-05
- Public Version Status
- New
- Public Device Record Key
- 771664b5-1009-438b-8132-1db402afc54d
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66677 | Vestibulo-auditory analysis system support kit¿ | A collection of reusable/consumable devices intended to be used with a vestibulo-auditory analysis system that typically includes two or more of the following: patient electrodes, cables/leads, an ear cup, conductive gel, ear tips and cleaning wipes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05711117232042 | GS1 | ||||
| Primary | 05711117099478 | GS1 |