Neuster Tp 0509
by Pms Tibbi Cihazlar Teknolojisi Sanayi Ve Ticaret Anonim Sirketi
Neuster Tp 0509 is a Class II device made by Pms Tibbi Cihazlar Teknolojisi Sanayi Ve Ticaret Anonim Sirketi, cleared under FDA 510(k) K160595 on 18 Nov 2016 and listed in FDA GUDID since 24 Jan 2023 (UDI-DI 10810105211884), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10810105211884 | Date24 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160595 | Date18 Nov 2016 | StatusActive |
Official records
- AccessGUDID record 10810105211884
- FDA 510(k) database K160595
Across registries
- FDA 510(k) K160595 decided 18 Nov 2016 Active
- FDA GUDID UDI-DI 10810105211884 listed 24 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K160595
- Listed FDA GUDID 10810105211884
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Neuster
- Generic name
- Sterilization packaging, single-use
- Model / reference
- TP 0509
- Description
- Sterilization Pouch made of DuPont™ Tyvek® 05 cm x 09 cm
- Primary DI / UDI-DI
- 10810105211884
- 510(k) Number
- FDA product code
- FRG
- GMDN term
- Sterilization packaging, single-use
- Device class
- Class II
- Regulation number
- 880.6850
- GUDID distribution status
- In Commercial Distribution
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