iTIND MT-SA20
by Medi-Tate, Ltd. Israel GUDID
Product code QKA
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290015518079 | Date10 Nov 2020 | StatusIn distribution |
Coverage
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- iTIND
- Generic Name
- Bare-metal urethral stent, short-term
- Model / Reference
- MT-SA20
- Primary DI / UDI-DI
- 07290015518079
- 510(k) Number
- FDA Product Code
- QKA
- GMDN Term
- Bare-metal urethral stent, short-term
- Device Class
- Class II
- Regulation Number
- 876.5510
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Conditional
Other devices from Medi-Tate, Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No
Sources (1)
- FDA UDI 8f6a3c16-b8c2-4b40-8177-f39234da3ecd