American Eagle Instruments
Excavator 78-79
2manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | American Eagle Instruments, United States |
|---|---|
| FDA product code | EMO |
| Device type | Knife, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-23 |
| Record revised | 2024-09-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2024-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AEKPAZ | Withdrawn | |
| AEKW1-2 | Withdrawn | |
| AEMCEXC5TNZ | Withdrawn | |
| AEKG38 | Withdrawn | |
| AEKG1-2 | Withdrawn | |
| AEMCEXC4TNZ | Withdrawn | |
| AEEXC78-79 | Withdrawn | |
| AEKOMZ | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 36 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 35 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 35 |
| Zoll Dental | Zoll-Dental | 25 |
| Stoma® | Storz AM Mark Gmbh | 25 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 18 |
| Osung MND | Osung MND Co., Ltd. | 15 |
| PDT, Inc. | PDT, Inc. | 14 |
| Laschal Surgical | Laschal Surgical Instruments, LLC | 13 |
| Knife | KLS-Martin L.P. | 8 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 7 |
| Otto Leibinger | American Eagle Instruments | 7 |
Showing 12 of 114. All products under Knife, Periodontic
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.