Diego
DIEGO HANDPIECE CLEANING KIT NONSTERILE .475” (12.07 mm) DIA and .0437” (11.10 mm) DIA STAINLESS WIRE, NYLON BRUSH CLEANING STEPS SEE USER MANUAL
2manufacturers in China registered for this device type
26catalogue numbers in this listing
3510(k) clearances naming this product 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 | Gyrus Acmi, Inc., United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K020594 |
| Record published | 2018-09-12 |
| Record revised | 2026-07-16 (version 7) |
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, manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 50 °C |
| Packaging | Pack of 6 |
| Distribution end date | 2026-04-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70138019 | In distribution | |
| 70338003 | In distribution | |
| 70338001 | In distribution | |
| 70339053 | In distribution | |
| 70338009 | In distribution | |
| 70339051 | In distribution | |
| 70139000 | In distribution | |
| 70339050R | In distribution | |
| 70338007 | In distribution | |
| 70339050 | In distribution | |
| 70139004 | In distribution | |
| 70338008 | In distribution | |
| 70139010 | In distribution | |
| 70339054R | In distribution | |
| 70338022 | In distribution | |
| 70338000R | In distribution | |
| 70339054 | In distribution | |
| 70339001R | In distribution | |
| 70339000R | In distribution | |
| 70139008 | In distribution | |
| 70339001 | Withdrawn | |
| 70139002 | Withdrawn | |
| 70339000 | Withdrawn | |
| 70338000 | Withdrawn | |
| 70139033 | Withdrawn | |
| 70139006 | Withdrawn |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 |
|---|---|
| K212650 | 2022-01-19 |
| K152744 | 2016-06-10 |
| K121678 | 2012-08-30 |
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.