FDA UDI
In Commercial Distribution
🇺🇸 United States
Tilt-Pro
DI: 10841962108604
·
Model: RT-4525TILTMRI
·
Qfix
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tilt-Pro
- Primary DI
- 10841962108604
- Version / Model
- RT-4525TILTMRI
- Catalog Number
- RT-4525TILTMRI
- Company Name
- Qfix
- Labeler DUNS
- 808875397
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 5
- Public Version Date
- 2023-12-11
- Public Version Status
- Update
- Public Device Record Key
- 142b2252-47da-401c-916c-f3b9b15de693
Device Description
Tilt-Pro Tilting Base MRI compatible version
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, linear, medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61110 | Radiation therapy treatment planning positioning kit | A collection of non-sterile devices intended to assist collection of diagnostic magnetic resonance imaging (MRI) images to be used as part of radiation therapy treatment planning. It includes multiple devices intended to ensure adequate positioning and/or immobilization of the patient during MRI imaging (e.g., radiological whole-body positioning frame/board, laser patient positioning system), and may include imaging supportive/reference devices (e.g., MRI phantom). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841962108604 | GS1 |
Customer Contacts
- Phone
- +1(610)268-0585
- [email protected]