FDA UDI
In Commercial Distribution
🇺🇸 United States
ACTILINK™
DI: 08800066500269
·
Model: ACTILINK reborn
·
Plasmapp Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACTILINK™
- Primary DI
- 08800066500269
- Version / Model
- ACTILINK reborn
- Company Name
- Plasmapp Co.,Ltd.
- Labeler DUNS
- 695798956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-24
- Public Version
- 1
- Public Version Date
- 2023-03-06
- Public Version Status
- New
- Public Device Record Key
- af9b9dd2-800c-4385-b13e-4296a63ff110
Device Description
The ACTILINK reborn is a device intended for use in reducing carbon contamination level on dental implant surface by means of plasma enhanced vacuuming, in a chairside.
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36305 | Plasma sterilizer | A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using vapours (or gases) in plasma state; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and then packed; a means to introduce the vapour [e.g., hydrogen peroxide (H2O2)] into the chamber; electrodes that are activated to convert the vapour into plasma; a radio-frequency generator; and cycle controls. The device is available in stand-alone (bulk) and tabletop units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800066500269 | GS1 |