Aesculap
BAKES Gall Duct Dilator, consisting of EB063R, EB064R, EB065R, EB066R, EB067R, EB068R, EB069R, EB070R, EB071R, non-sterile, reusable, to be used with: EB075, Set
Dilator, Esophageal (Metal Olive) Gastro-Urology
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Shanghai.
- Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
What Is FDA Product Code EZM?
Dilator, Esophageal (Metal Olive) Gastro-Urology is FDA product code EZM, Class 2, 21 CFR 876.5365.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
Name
Record