Elan 4
Elan 4 MIS Handpiece Shaft L13 Heavy-CVD
1manufacturer
39catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Rainbow Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 12 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | HBC |
| Device type | Motor, Drill, Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-08-10 |
| Record revised | 2021-11-10 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2022-03-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GA860 | In distribution | |
| GA805 | In distribution | |
| GB927R | In distribution | |
| GP580R | In distribution | |
| GB088R | In distribution | |
| GP598SU | In distribution | |
| GA824 | In distribution | |
| GA837 | In distribution | |
| GP588SU | In distribution | |
| GA836 | In distribution | |
| GB922R | In distribution | |
| GA822 | In distribution | |
| GA849 | In distribution | |
| GP583SU | In distribution | |
| GA864 | In distribution | |
| GP581SU | In distribution | |
| GP590R | In distribution | |
| GA804 | In distribution | |
| GP587SU | In distribution | |
| GA808 | In distribution | |
| GP586R | In distribution | |
| GA861 | In distribution | |
| GP595SU | In distribution | |
| GP584SU | In distribution | |
| GP591SU | In distribution | |
| GA863 | In distribution | |
| GP594SU | In distribution | |
| GA862 | In distribution | |
| GA806 | In distribution | |
| GA833 | In distribution | |
| GP582R | In distribution | |
| GB928R | Withdrawn | |
| GA869 | Withdrawn | |
| GA867 | Withdrawn | |
| GA868 | Withdrawn | |
| GA832 | Withdrawn | |
| GA866 | Withdrawn | |
| GA865 | Withdrawn | |
| GA831 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NSK Sterile Burs/Drills | Nakanishi Inc. | 447 |
| Motor, Drill, Electric | Anspach Effort, The | 168 |
| Primado2 | Nakanishi Inc. | 96 |
| Midas REX® | Medtronic Powered Surgical Solutions | 29 |
| NSK Sterile Blades | Nakanishi Inc. | 24 |
| Motor, Drill, Electric | Synthes Gmbh | 22 |
| Aesculap | Aesculap AG | 14 |
| SSG10 | Saeshin Precision Co., Ltd. | 11 |
| Traus | Saeshin Precision Co., Ltd. | 9 |
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 7 |
| Eccos | Aesculap AG | 7 |
| Motor, Drill, Electric | Medtronic Xomed, Inc. | 6 |
Showing 12 of 75. All products under Motor, Drill, Electric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152960 | 2016-07-22 |
| K053526 | 2006-01-18 |
| K003612 | 2001-02-20 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-11-22 | Not classified | Software design | Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion. | 91 units | 2012-07-05 |
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.