FDA UDI
In Commercial Distribution
🇺🇸 United States
Solstat™ Immobilization System
DI: 00841439112502
·
Model: CHS05
·
MEDTEC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Solstat™ Immobilization System
- Primary DI
- 00841439112502
- Version / Model
- CHS05
- Catalog Number
- CHS05
- Company Name
- MEDTEC, INC.
- Labeler DUNS
- 103977526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-07
- Public Version
- 2
- Public Version Date
- 2019-05-30
- Public Version Status
- Update
- Public Device Record Key
- 54c9cdc1-5e9b-4e4d-9949-f8aca8fff567
Device Description
Head support system for use with Posifix® systems
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNH | System, nuclear magnetic resonance imaging | Radiology | 892.1000 | 2 |
| IYE | Accelerator, linear, medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61132 | Radiological headrest | A non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841439112502 | GS1 |
Customer Contacts
- Phone
- +1(712)737-8688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182079 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 11.35 | Inch | |
| Width | 9.74 | Inch |