FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Thermoplastic Frame
DI: 00841439107126
·
Model: MTRFH2
·
MEDTEC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thermoplastic Frame
- Primary DI
- 00841439107126
- Version / Model
- MTRFH2
- Catalog Number
- MTRFH2
- Company Name
- MEDTEC, INC.
- Labeler DUNS
- 103977526
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-02
- Public Version
- 5
- Public Version Date
- 2019-03-20
- Public Version Status
- Update
- Public Device Record Key
- 2fcbfc63-5e23-4f37-8822-88d2db5f8c97
- Distribution End Date
- 2019-03-20
Device Description
Reloadable non-sterile thermoplastic frame set
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, linear, medical | Radiology | 892.5050 | 2 |
| LNH | System, nuclear magnetic resonance imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40899 | Radiological breast positioner, non-wearable | A device that is specifically designed to ensure adequate positioning and immobilization of the female patient's breast(s) and chest during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, board, cushion, or preformed pad (non-wearable device) and may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841439107126 | GS1 |
Customer Contacts
- Phone
- +1(712)737-8688
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 2.5 | Centimeter | |
| Length | 44.5 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight