Dukal UPP-1015
by Dukal LLC
Dukal UPP-1015 is a Class II device made by Dukal LLC, cleared under FDA 510(k) K162258 on 28 Apr 2017 and listed in FDA GUDID since 1 Jun 2025 (UDI-DI 20665973032454), 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 | Number20665973032454 | Date1 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162258 | Date28 Apr 2017 | StatusActive |
Official records
- AccessGUDID record 20665973032454
- FDA 510(k) database K162258
Across registries
- FDA 510(k) K162258 decided 28 Apr 2017 Active
- FDA GUDID UDI-DI 20665973032454 listed 1 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K162258
- Listed FDA GUDID 20665973032454
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dukal
- Generic name
- Sterilization packaging, single-use
- Model / Ref / Catalog
- UPP-1015
- Primary DI / UDI-DI
- 20665973032454
- 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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