Si-2 106119
by BIOTRONIK SE & Co. KG GUDID
Listed
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04035479145262 | Date25 Aug 2014 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- Si-2
- Generic Name
- Implantable-device lubricant
- Model / Ref / Catalog
- 106119
- Primary DI / UDI-DI
- 04035479145262
- PMA Number
- FDA Product Code
- DTB
- GMDN Term
- Implantable-device lubricant
- Device Class
- Class III
- Regulation Number
- 870.3680
- GUDID distribution status
- In Commercial Distribution
Other devices from BIOTRONIK SE & Co. KG
Properties
Other properties (8)
- 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