FDA UDI
In Commercial Distribution
🇺🇸 United States
Proutra™
DI: 00841439102763
·
Model: MT6X300R
·
MEDTEC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Proutra™
- Primary DI
- 00841439102763
- Version / Model
- MT6X300R
- Catalog Number
- MT6X300R
- Company Name
- MEDTEC, INC.
- Labeler DUNS
- 103977526
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-02
- Public Version
- 4
- Public Version Date
- 2019-05-31
- Public Version Status
- Update
- Public Device Record Key
- 9258de4c-7a9e-4d60-9dc8-42a58481dd07
Device Description
Reconditioned, for use with Varian Exact™ bases
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| JAI | Couch, radiation therapy, powered | Radiology | 892.5770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40687 | Accelerator system table, powered | An electrically-powered and/or programmable radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs that includes electronic and/or software controls for top height adjustments and positioning. It may be an independent device that is stationary or mobile, or it can be an integral component of a medical accelerator system design. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841439102763 | GS1 |
Customer Contacts
- Phone
- +1(712)737-8688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132084 | 000 |