Drill, Surgical, Ent (Electric or Pneumatic) Including Handpiece
Larynx Shaver Attach., Ø 4mm, 5x sterile
2manufacturers in China registered for this device type
208catalogue numbers in this listing
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 | Karl Storz GmbH & Co. KG |
|---|---|
| FDA product code | ERL |
| Device type | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4250 |
| 510(k) | K021811 |
| Record published | 2016-09-23 |
| Record revised | 2024-10-21 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 649614 | In distribution | ||
| 649631 | In distribution | ||
| 40800122 | In distribution | ||
| 260045 | In distribution | ||
| 660074SK | In distribution | ||
| 20711033 | In distribution | ||
| 260023 | In distribution | ||
| 41303WN | 5 | In distribution | |
| 649670L | In distribution | ||
| 649723K | In distribution | ||
| 41303KKF | 5 | In distribution | |
| 649631K | In distribution | ||
| 031131-10 | 10 | In distribution | |
| 649727K | In distribution | ||
| 649760K | In distribution | ||
| 649731L | In distribution | ||
| 265070 | In distribution | ||
| 649640K | In distribution | ||
| 649640HK | In distribution | ||
| 260027 | In distribution | ||
| 252690 | In distribution | ||
| 649727GL | In distribution | ||
| 649745GK | In distribution | ||
| 41301GN | 5 | In distribution | |
| 260035 | In distribution | ||
| 649760GL | In distribution | ||
| 252571 | In distribution | ||
| 41304KKBA | 5 | In distribution | |
| 649750 | In distribution | ||
| 40712035 | In distribution | ||
| 649627L | In distribution | ||
| 252672 | In distribution | ||
| 649727G | In distribution | ||
| 41303KNF | 5 | In distribution | |
| 41201KK | In distribution | ||
| 20711680 | In distribution | ||
| 649770K | In distribution | ||
| 649723GK | In distribution | ||
| 649770L | In distribution | ||
| 649723 | In distribution | ||
| 649623HK | In distribution | ||
| 649760L | In distribution | ||
| 649718 | In distribution | ||
| 649731GK | In distribution | ||
| 268010 | In distribution | ||
| 649627K | In distribution | ||
| 252414 | In distribution | ||
| 649735GL | In distribution | ||
| 41301KSA | 5 | In distribution | |
| 649631HK | In distribution | ||
| 649714 | In distribution | ||
| 260008 | In distribution | ||
| 660074SF | In distribution | ||
| 649745GL | In distribution | ||
| 649718K | In distribution | ||
| 649645HK | In distribution | ||
| 649745K | In distribution | ||
| 649750GK | In distribution | ||
| 660074SG | In distribution | ||
| 260010 | In distribution | ||
| 260060 | In distribution | ||
| 649650 | In distribution | ||
| 649640L | In distribution | ||
| 649770 | In distribution | ||
| 260040 | In distribution | ||
| 268008 | In distribution | ||
| 252611 | In distribution | ||
| 649740G | In distribution | ||
| 649635 | In distribution | ||
| 252615 | In distribution | ||
| 649731 | In distribution | ||
| 649750GL | In distribution | ||
| 649735 | In distribution | ||
| 649731G | In distribution | ||
| 41305RN | 5 | In distribution | |
| 41303GNF | 5 | In distribution | |
| 265050 | In distribution | ||
| 41303KKB | 5 | In distribution | |
| 649727 | In distribution | ||
| 649723L | In distribution | ||
| 649735K | In distribution | ||
| 41303KKBA | 5 | In distribution | |
| 41305D | 5 | In distribution | |
| 649727GK | In distribution | ||
| 41304KKFA | 5 | In distribution | |
| 252610 | In distribution | ||
| 649623L | In distribution | ||
| 649635HK | In distribution | ||
| 260070 | In distribution | ||
| 260007 | In distribution | ||
| 41201KSA | In distribution | ||
| 649618HK | In distribution | ||
| 649614L | In distribution | ||
| 649670HK | In distribution | ||
| 41201LN | In distribution | ||
| 649660L | In distribution | ||
| 260006 | In distribution | ||
| 41301KKSB | 5 | In distribution | |
| 269000 | In distribution | ||
| 649770GL | In distribution | ||
| 263518 | In distribution | ||
| 41301LSA | 5 | In distribution | |
| 649735G | In distribution | ||
| 649760G | In distribution | ||
| 649723G | In distribution | ||
| 41303KNB | 5 | In distribution | |
| 252411 | In distribution | ||
| 649740GK | In distribution | ||
| 40201NN | In distribution | ||
| 649650HK | In distribution | ||
| 263523D | In distribution | ||
| 649745 | In distribution | ||
| 649731K | In distribution | ||
| 649660HK | In distribution | ||
| 649750G | In distribution | ||
| 41303DT | 5 | In distribution | |
| 41201KKSA | In distribution | ||
| 263521 | In distribution | ||
| 40201GN | In distribution | ||
| 649645L | In distribution | ||
| 41301SN | 5 | In distribution | |
| 649618K | In distribution | ||
| 41301LN | 5 | In distribution | |
| 41301KN | 5 | In distribution | |
| 649731GL | In distribution | ||
| 649627 | In distribution | ||
| 263523 | In distribution | ||
| 41201GN | In distribution | ||
| 649740 | In distribution | ||
| 649714L | In distribution | ||
| 649745L | In distribution | ||
| 649727L | In distribution | ||
| 649718L | In distribution | ||
| 40201RN | In distribution | ||
| 649623 | In distribution | ||
| 252570 | In distribution | ||
| 649740GL | In distribution | ||
| 649645 | In distribution | ||
| 254316 | 12 | In distribution | |
| 41305DN | 5 | In distribution | |
| 41201KN | In distribution | ||
| 252692 | In distribution | ||
| 20711621 | In distribution | ||
| 649670 | In distribution | ||
| 254315 | 12 | In distribution | |
| 41304KKF | 5 | In distribution | |
| 260014 | In distribution | ||
| 649650L | In distribution | ||
| 649650K | In distribution | ||
| 649660 | In distribution | ||
| 649770G | In distribution | ||
| 20711073 | In distribution | ||
| 649618 | In distribution | ||
| 41304KKB | 5 | In distribution | |
| 41201LSA | In distribution | ||
| 260031 | In distribution | ||
| 649714K | In distribution | ||
| 649614K | In distribution | ||
| 41301KKSA | 5 | In distribution | |
| 649760 | In distribution | ||
| 41303GNB | 5 | In distribution | |
| 649631L | In distribution | ||
| 649760GK | In distribution | ||
| 41201SN | In distribution | ||
| 649735GK | In distribution | ||
| 649627HK | In distribution | ||
| 40201LN | In distribution | ||
| 523100 | In distribution | ||
| 649735L | In distribution | ||
| 649750K | In distribution | ||
| 649614HK | In distribution | ||
| 649740K | In distribution | ||
| 41201KKSB | In distribution | ||
| 40201SN | In distribution | ||
| 41301LX | 5 | In distribution | |
| 649740L | In distribution | ||
| 649635K | In distribution | ||
| 264070 | In distribution | ||
| 40201KN | In distribution | ||
| 649618L | In distribution | ||
| 41303KKFA | 5 | In distribution | |
| 41304W | 5 | In distribution | |
| 252410 | In distribution | ||
| 41301KK | 5 | In distribution | |
| 649623K | In distribution | ||
| 254314 | 12 | In distribution | |
| 260050 | In distribution | ||
| 523010 | In distribution | ||
| 649635L | In distribution | ||
| 649640 | In distribution | ||
| 649745G | In distribution | ||
| 649670K | In distribution | ||
| 252612 | In distribution | ||
| 252660 | In distribution | ||
| 649723GL | In distribution | ||
| 523000 | In distribution | ||
| 260018 | In distribution | ||
| 649645K | In distribution | ||
| 265060 | In distribution | ||
| 649660K | In distribution | ||
| 41302KN | 5 | In distribution | |
| 268015 | In distribution | ||
| 252490 | In distribution | ||
| 41305DW | 5 | In distribution | |
| 649770GK | In distribution | ||
| 41301LXA | 5 | In distribution | |
| 40712090 | In distribution | ||
| 649750L | In distribution |
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 | 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 |
| Core | Stryker GmbH | 27 |
Showing 12 of 169. All products under Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
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.