FDA UDI
In Commercial Distribution
🇺🇸 United States
DC-Air™ Docking Station
DI: 06429810587039
·
Model: WIOS-DS2
·
Athlos Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DC-Air™ Docking Station
- Primary DI
- 06429810587039
- Version / Model
- WIOS-DS2
- Company Name
- Athlos Oy
- Labeler DUNS
- 368444471
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-10
- Public Version
- 3
- Public Version Date
- 2022-11-07
- Public Version Status
- Update
- Public Device Record Key
- f1133ed7-24de-4ac9-8b57-fe30235c946b
Device Description
DC-Air™ Docking Station is intended for use as a data transfer pathway between the DC-Air™ Intraoral Sensor and a PC or laptop, and as a charging station for the DC-Air™ Intraoral Sensor.
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
- Yes
- 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 |
|---|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64667 | Noninvasive device battery charger/transceiver/cable | An electrically-powered device designed to supply an electrical charge to the battery of a noninvasive device to recharge it for operation, and to both receive data from and transmit data to noninvasive devices via a direct/wired or wireless connection. It is typically in the form of an electronic circuitry housing with a cable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06429810587039 | GS1 | ||||
| Package | 06429810587091 | GS1 | 1 | In Commercial Distribution |