| Primary Device ID | 00841439113066 |
| NIH Device Record Key | 35d93065-8fe9-4a6f-84cb-98ffeab12b14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cushion Guide |
| Version Model Number | PRO350 |
| Catalog Number | PRO350 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841439113066 [Primary] |
| IYE | Accelerator, linear, medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-18 |
| Device Publish Date | 2019-10-10 |
| 00841439114650 - Pronumbra | 2025-09-22 Pronumbra Helping Hand, Left |
| 00841439114674 - Pronumbra | 2025-09-22 Pronumbra Helping Hand, Right |
| 00841439114681 - Pronumbra | 2025-09-22 Pronumbra 130cm kVue |
| 00841439114698 - Pronumbra | 2025-09-22 Pronumbra Neck Support, 40mm |
| 00841439114704 - Pronumbra | 2025-09-22 Pronumbra Neck Support, 50mm |
| 00841439114711 - Pronumbra | 2025-09-22 Pronumbra Neck Support, 65mm |
| 00841439114728 - Pronumbra | 2025-09-22 Pronumbra Shoulder Adapter |
| 00841439114841 - ZiFix Traverse | 2025-09-22 ZiFix Traverse with ONEClamp |