AGILON® resection guide revision to invers 78200580
by implantcast GmbH EUDAMEDGUDID
Active
Ref 78200580Model SH15RGRIINST
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number4048844SH15RGRIINST3F | Date13 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04048844533731 | Date6 Sep 2022 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Trade Name
- Agilon® EUDAMEDAGILON® resection guide revision to invers GUDID
- Generic Name
- Orthopaedic fixation implant alignment tool
- Model / Reference
- 78200580, SH15RGRIINST
- Primary DI / UDI-DI
- 04048844533731
- Basic UDI-DI
- 4048844SH15RGRIINST3F
- Direct Marketing DI
- 04048844533731
- FDA Product Code
- LXH
- EMDN Code
- L091199 Orthopaedic prosthetics instruments, reusable - other
- GMDN Term
- Orthopaedic fixation implant alignment tool
- Device Class
- Class I
- Regulation Number
- 888.4540
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from implantcast GmbH
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No