| Primary Device ID | 08717213054882 |
| NIH Device Record Key | d00030e6-ab58-4b64-a39c-1c4ac6c13871 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Advanced Gynecological Applicator |
| Version Model Number | 126013-01 |
| Company DUNS | 415269930 |
| Company Name | Nucletron B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(770)300-9725 |
| info.america@elekta.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717213054882 [Direct Marking] |
| GS1 | 08717213055001 [Primary] |
| JAQ | System, applicator, radionuclide, remote-controlled |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08717213054882]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-12 |
| Device Publish Date | 2020-02-04 |
| 08717213054325 | Number Tags For Guiding Tubes |
| 08717213054318 | Bracelet For Guiding Tubes |
| 08717213054790 | Interstitial Lunar Ovoid Tube 26mm 60° Right |
| 08717213054783 | Interstitial Lunar Ovoid Tube 22mm 60° Left |
| 08717213054776 | Interstitial Lunar Ovoid Tube 22mm 60° Right |
| 08717213055032 | Intrauterine Tube 40mm 30° |
| 08717213054899 | Intrauterine Tube 30mm 30° |
| 08717213054882 | Intrauterine Tube 0mm |
| 08717213054813 | Interstitial Lunar Ovoid Tube 30mm 60° Left |
| 08717213054806 | Interstitial Lunar Ovoid Tube 30mm 60° Right |
| 08717213054752 | Interstitial Lunar Ovoid Tube 26mm 60° Left |
| 08717213054905 | Vaginal Cap 30mm Left |
| 08717213054912 | Vaginal Cap 30mm Right |
| 08717213054929 | Vaginal Cap 26mm Left |
| 08717213055797 | Vaginal Cap 26mm Right |
| 08717213055773 | Vaginal Cap 22mm Left |
| 08717213055742 | Vaginal Cap 22mm Right |
| 08717213055643 | Interstitial lever |
| 08717213055629 | Perineal Bar |
| 08717213055599 | Perineal Template Ventral 0° |
| 08717213055575 | Perineal Template Dorsal 12° |
| 08717213055551 | Perineal Template Dorsal 0° |
| 08717213055544 | Fixation Clip |
| 08717213055513 | Fixation Element |
| 08717213054844 | Intrauterine Tube 70mm 15° |
| 08717213055124 | Intrauterine Tube 60mm 15° |
| 08717213054820 | Intrauterine Tube 50mm 15° |
| 08717213054868 | Intrauterine Tube 40mm 15° |
| 08717213054875 | Intrauterine Tube 30mm 15° |
| 08717213055070 | Intrauterine Tube 70mm 30° |
| 08717213054851 | Intrauterine Tube 60mm 30° |
| 08717213054837 | Intrauterine Tube 50mm 30° |