ONEPlatform™ - Short BPL004
GUDID 00841439102305
ONEPlatform™ - Short
MEDTEC, INC.
Radiological whole-body positioner| Primary Device ID | 00841439102305 |
| NIH Device Record Key | 0af9e377-a817-46d8-95cc-b516a5ee22fb |
| Commercial Distribution Discontinuation | 2020-01-02 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ONEPlatform™ - Short |
| Version Model Number | BPL004 |
| Catalog Number | BPL004 |
| 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 | false |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
| Phone | +1(712)737-8688 |
| radiotherapy.complaints@civcort.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841439102305 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111340
FDA Product Code
| IYE | Accelerator, linear, medical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 9 |
| Public Version Date | 2020-01-02 |
| Device Publish Date | 2017-08-02 |
Devices Manufactured by MEDTEC, INC.
| 00841439114766 - Universal Couchtop™ | 2024-10-28 with Lok-Bar™ and rectangular extension |
| 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) |
Trademark Results [ONEPlatform]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONEPLATFORM 87066945 5268927 Live/Registered |
Big Data Experts, LLC 2016-06-10 |
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