| Primary Device ID | 00841439100431 |
| NIH Device Record Key | 946b0cfa-cd37-4318-9ee9-a71c2c077dbf |
| Commercial Distribution Discontinuation | 2018-04-13 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Posifix Overlay |
| Version Model Number | 108070 |
| Catalog Number | 108070 |
| Company DUNS | 103977526 |
| Company Name | MEDTEC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| 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(712)737-8688 |
| radiotherapy.complaints@civcort.com |
| Length | 39.25 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841439100431 [Primary] |
| HIBCC | M36610807008 [Secondary] |
| IYE | Accelerator, linear, medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-02 |
| 00841439114667 - GE MR Posifix® Baseplate | 2024-10-09 Acrylic Baseplate |
| 00841439114759 - Rectangular Extension | 2024-10-09 For use with Universal Couchtop™ Long Extension |
| 00841439114612 - Wedge | 2024-07-17 5 degree wedge, MR |
| 00841439114629 - Spacer | 2024-07-17 20mm spacer, MR |
| 00841439114636 - Spacer | 2024-07-17 30mm spacer, MR |
| 00841439114643 - Wedge and Spacer Set | 2024-07-17 2.5 degree wedge, 5 degree wedge, 20mm spacer, and 30mm spacer, MR |
| 10841439114589 - BrachyGel Vaginal Hydrogel Packing System | 2024-05-31 BrachyGel Vaginal Hydrogel Packing System (BVHPS) |
| 00841439114599 - Pro Posifix® Headrest Adapter | 2024-05-24 Pro Posifix® Headrest Adapter |