Device product
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Z-0582-2026
Product summary
- Event
- Event 97753
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 61 units
- Official record key
device-enforcement:Z-0582-2026
Official wording
Reason: The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Code information: 1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;
Distribution pattern: US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
Derived failure modes
-
Unknown
The possibility for this product that is intended for demonstration purposes only to be placed in patients.