Device product
Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Z-2117-2024
Product summary
- Event
- Event 94520
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 360500
- Official record key
device-enforcement:Z-2117-2024
Official wording
Reason: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Code information: Lot Code: LOT: SL21030105,SL21040104,SL21070104,SL21090105,SL21110104,SL21 110304,SL21120104,SL22030105,SL22070106,SL22100205,SL221202 03,SL23020204,SL23080305,SL23100405,SL23120405
Distribution pattern: U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.
Derived failure modes
-
Unknown
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).