| Primary Device ID | 08717213032095 |
| NIH Device Record Key | e9da21b6-183d-44fc-825f-22c016702e94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Valencia Skin Applicator |
| Version Model Number | 110822-00 |
| Company DUNS | 415269930 |
| Company Name | Nucletron B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(770)300-9725 |
| info.america@elekta.com |
| Outer Diameter | 30 Millimeter |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717213032095 [Primary] |
| JAQ | System, applicator, radionuclide, remote-controlled |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08717213032095]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-30 |
| Device Publish Date | 2019-09-21 |
| 08717213031852 | Advanced Skin Applicator Set |
| 08717213032095 | Valencia Ft Skin Applicator, 30mm |
| 08717213032071 | Valencia Ft Skin Applicator, Ø 20mm |
| 08717213032057 | Valencia Skin Applicator, 30mm |
| 08717213032033 | Valencia Skin Applicator, Ø 20mm |