Leader 5851845
Leader 5851845 is a sexual lubricant (FDA Class II; FDA product code NUC, Lubricant, personal) made by Cardinal Health 110, Inc., cleared under FDA 510(k) K180923 on 9 Jul 2018 and listed in FDA GUDID since 7 Oct 2024 (UDI-DI 00096295142860), 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 | Number00096295142860 | Date7 Oct 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180923 | Date9 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 00096295142860
- FDA 510(k) database K180923
Across registries
- FDA 510(k) K180923 decided 9 Jul 2018 Active
- FDA GUDID UDI-DI 00096295142860 listed 7 Oct 2024 Listed
Timeline
- Cleared FDA 510(k) K180923
- Listed FDA GUDID 00096295142860
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Leader
- Generic name
- Sexual lubricant
- Model / Ref / Catalog
- 5851845
- Primary DI / UDI-DI
- 00096295142860
- 510(k) Number
- FDA product code
- NUC
- GMDN term
- Sexual lubricant
- Device class
- Class II
- Regulation number
- 884.5300
- GUDID distribution status
- In Commercial Distribution
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