2011年 3月 30日
According to informal discussions with the FDA, proper use of AofC codes can reduce the Customs processing time from several days to a matter of minutes.
Code | Description | Qualifier |
---|---|---|
CPT | Device Component | n/a |
DEV | Device Foreign Manufacturer Registration Number | Establishment Registration number |
DFE | Device Foreign Exporter Registration Number | Establishment Registration number |
DII | Device Initial Importer Registration Number | Establishment Registration number |
IDE | Investigational Device Exemption Number | IDE number |
IFE | Import for Export | n/a |
IRC | Impact Resistance Lens Certification | n/a |
LST | Device Listing Number | Device listing number from FURLS |
LWC | Lead Wire or Patient Cable | n/a |
MDL | Model Number | Manufacturer's model number |
PMA | Device Premarket Approval Number | PMA number |
PMN | Device Premarket Notification Number (510(k)) | 510(k) number |