Solstat™ Immobilization System CHS14
GUDID 00841439113448
Solstat™ Immobilization System
MEDTEC, INC.
Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest Radiological headrest 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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