Solstat™ Immobilization System CHS14
GUDID 00841439113448
Solstat™ Immobilization System
MEDTEC, INC.
Radiological headrest| Primary Device ID | 00841439113448 |
| NIH Device Record Key | 5e17a5b8-692f-4c4a-9ae3-57605e16a6be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Solstat™ Immobilization System |
| Version Model Number | CHS14 |
| Catalog Number | CHS14 |
| Company DUNS | 103977526 |
| Company Name | MEDTEC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841439113448 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182079
FDA Product Code
| LNH | System, nuclear magnetic resonance imaging |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-31 |
| Device Publish Date | 2021-05-22 |
On-Brand Devices [Solstat™ Immobilization System]
| 00841439112519 | Head support system for use with Type-S™ systems |
| 00841439112502 | Head support system for use with Posifix® systems |
| 00841439113448 | Solstat™ Immobilization System |
Trademark Results [Solstat]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLSTAT 87895213 not registered Dead/Abandoned |
Medtec, Inc. 2018-04-27 |
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