| Primary Device ID | 08717213057258 |
| NIH Device Record Key | 3ebfb8f7-6afb-490c-ae03-0d0358f175d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smit Sleeve |
| Version Model Number | 129117-00 |
| Company DUNS | 415269930 |
| Company Name | Nucletron B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com | |
| Phone | +17703009725 |
| info.america@elekta.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717213057227 [Primary] |
| GS1 | 08717213057258 [Package] Contains: 08717213057227 Package: [5 Units] In Commercial Distribution |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-15 |
| Device Publish Date | 2024-07-05 |
| 08717213057258 | Smit Sleeve CT/MR, 4mm |
| 08717213057203 | Sleeve CT/MR Intrauterine Tube |