Aesculap
Drill Attachm.small Jacobs F/GA344/GA844
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-04-30 |
| Record revised | 2021-05-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2021-10-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GB882R | In distribution | ||
| GB886R | In distribution | ||
| GB894R | In distribution | ||
| GB884R | In distribution | ||
| GB870R | In distribution | ||
| GB897R | In distribution | ||
| GB892R | In distribution | ||
| GB872R | In distribution | ||
| GB887R | In distribution | ||
| GB896R | In distribution | ||
| GB891R | In distribution | ||
| GB871R | In distribution | ||
| GB881R | In distribution | ||
| GP491R | 5 | Withdrawn | |
| GP492R | 5 | Withdrawn | |
| GP495R | 5 | Withdrawn | |
| GP493R | 5 | Withdrawn | |
| GB266M | Withdrawn | ||
| GP543R | 5 | Withdrawn | |
| GP542R | 5 | Withdrawn | |
| GP496R | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas REX MR8 | Medtronic Powered Surgical Solutions | 1,006 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker GmbH | 948 |
| Elan 4 | Aesculap AG | 529 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Synthes Gmbh | 514 |
| Zethon | Zethon Ltd | 237 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker Leibinger Gmbh & Co. KG | 220 |
| Midas Rex® | Medtronic Powered Surgical Solutions | 167 |
| HiCUT Burs | Adeor Medical AG | 90 |
| Phasor | Phasor Health, LLC | 80 |
| Traumaone System | Biomet Microfixation | 62 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 60 |
| Mids REX MR8 | Medtronic Powered Surgical Solutions | 59 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203739 | 2021-08-24 |
| K183203 | 2019-08-09 |
| K182527 | 2019-01-19 |
| K172709 | 2018-10-17 |
| K022942 | 2002-10-21 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. 3 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-09-05 | Class II | No Marketing Application | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | 6211 | 2019-09-20 |
| 2017-09-05 | Class II | No Marketing Application | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | 10984 | 2019-09-20 |
| 2017-09-05 | Class II | No Marketing Application | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | 6211 | 2019-09-20 |
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.