Pmam 1122 125mm
2 catalogue numbers from 1600337, listed by Bien-AIR Surgery SA, Switzerland, under Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Bien-AIR Surgery SA, Switzerland |
|---|---|
| FDA product code | ERL |
| Device type | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4250 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K792159 |
| Record published | 2019-01-07 |
| Record revised | 2023-02-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1600337 | In distribution | |
| 1600337 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ENT MR8 | Medtronic Powered Surgical Solutions | 234 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Anspach Effort, The | 214 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Karl Storz GmbH & Co. KG | 208 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Synthes Gmbh | 126 |
| Midas Rex | Medtronic Powered Surgical Solutions | 97 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Stryker GmbH | 87 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 75 |
| Piezomed Pro Accessory | W&H Dentalwerk Bürmoos GmbH | 50 |
| Midas Rex Clearview™ | Medtronic Xomed, Inc. | 47 |
| Zethon | Zethon Ltd | 39 |
| NSK Sterile Burs/Drills | Nakanishi Inc. | 34 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Medtronic Xomed, Inc. | 29 |
Showing 12 of 169. All products under Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221184 | 2022-11-02 |
| K143492 | 2015-03-04 |
| K083720 | 2009-03-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Bien-AIR Surgery SA | 510(k) number | 2020-09-11 | Class II | Process control | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Total US = 1120 foot pedals |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2020-09-11 | Class II | Process control | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | |
| 2020-09-11 | Class II | Process control | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Total US = 1120 foot pedals |
| 2020-09-11 | Class II | Process control | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Total US = 1120 foot pedals |
| 2020-09-11 | Class II | Process control | The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor. | Total US = 1120 foot pedals |
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.