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
1manufacturer
14catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | EZM |
| Device type | Dilator, Esophageal (Metal Olive) Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5365 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2023-07-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EB065R | In distribution | |
| EB069R | In distribution | |
| EB070R | In distribution | |
| EB063R | In distribution | |
| EB066R | In distribution | |
| EB072R | In distribution | |
| EB074R | In distribution | |
| EB061R | In distribution | |
| EB068R | In distribution | |
| EB073R | In distribution | |
| EB062R | In distribution | |
| EB067R | In distribution | |
| EB064R | In distribution | |
| EB071R | In distribution |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.