TenderTrode Plus™ A10008
by Graphic Controls Acquisition Corp
TenderTrode Plus™ A10008 is a Class II device made by Graphic Controls Acquisition Corp, cleared under FDA 510(k) K915831 on 8 Jun 1992 and listed in FDA GUDID since 2 Mar 2018 (UDI-DI 10813150020579), 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 | Number10813150020579 | Date2 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK915831 | Date8 Jun 1992 | StatusActive |
Official records
- AccessGUDID record 10813150020579
- FDA 510(k) database K915831
Across registries
- FDA 510(k) K915831 decided 8 Jun 1992 Active
- FDA GUDID UDI-DI 10813150020579 listed 2 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K915831
- Listed FDA GUDID 10813150020579
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TenderTrode Plus™
- Generic name
- Cable/lead/sensor/probe cover, non-sterile
- Model / Ref / Catalog
- A10008
- Description
- Thermal Probe Cover 20/pouch, 10 pouches/case, 500 per case
- Primary DI / UDI-DI
- 10813150020579
- 510(k) Number
- FDA product code
- FMT
- GMDN term
- Cable/lead/sensor/probe cover, non-sterile
- Device class
- Class II
- Regulation number
- 880.5130
- GUDID distribution status
- In Commercial Distribution