Medline
31315066U @ultra RND STL Ctng BUR, 8 FLT
5manufacturers in China registered for this device type
36catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Zonefly Medical Devices Co., Ltd. | Danyang | Jiangsu | Specification developer | 7 |
| Guizhou Zirui Technology Co., Ltd. | Tongzi County, Zunyi | Guizhou | Manufacturer | 4 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | EQJ |
| Device type | Bur, Ear, Nose And Throat |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4140 |
| Premarket notification | Exempt |
| Record published | 2022-04-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16086159RH | In distribution | |
| 31112070R | In distribution | |
| 31311570R | In distribution | |
| 31315066UR | In distribution | |
| 31312070R | In distribution | |
| 110016100R | In distribution | |
| 110015900R | In distribution | |
| 3112910CR | In distribution | |
| 31317057UR | In distribution | |
| 31314053UR | In distribution | |
| 31315047UR | In distribution | |
| 31146051AR | In distribution | |
| 70327039RH | In distribution | |
| 31141564R | In distribution | |
| 3112974CR | In distribution | |
| 31061075R | In distribution | |
| 31142075R | In distribution | |
| 31312569R | In distribution | |
| 110015600R | In distribution | |
| 31311056R | In distribution | |
| 3127657R | In distribution | |
| 31314068UR | In distribution | |
| 3155635R | In distribution | |
| 31142364R | In distribution | |
| 110015400R | In distribution | |
| 31316046UR | In distribution | |
| 31314065UR | In distribution | |
| 31147051AR | In distribution | |
| 110015700R | In distribution | |
| 31316058UR | In distribution | |
| 31144051AR | In distribution | |
| 31317045UR | In distribution | |
| 3127656R | In distribution | |
| 110016400R | In distribution | |
| 31313065UR | In distribution | |
| 31152090ERH | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bur, Ear, Nose And Throat | Medtronic Xomed, Inc. | 413 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 99 |
| Diego Elite | Gyrus Acmi, Inc. | 97 |
| Jedmed | Jedmed Instrument Company | 88 |
| Diego | Gyrus Acmi, Inc. | 56 |
| RAD® | Medtronic Xomed, Inc. | 53 |
| Invotec ENT Bur | Invotec International, Inc. | 50 |
| NSK Sterile Burs/Drills | Nakanishi Inc. | 46 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 41 |
| Bur, Ear, Nose And Throat | Karl Storz GmbH & Co. KG | 39 |
| Tricut® | Medtronic Xomed, Inc. | 31 |
| Bur, Ear, Nose And Throat | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 30 |
Showing 12 of 646. All products under Bur, Ear, Nose And Throat
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.