Gyrus Acmi
Mastoid Round Cutting Burr Sterile 3.00MM Diameter X 80MM Length Stainless Steel Disposable
5manufacturers in China registered for this device type
99catalogue numbers in this listing
1recall
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 | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | EQJ |
| Device type | Bur, Ear, Nose And Throat |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4140 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-12 |
| Record revised | 2024-09-02 (version 5) |
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 |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70326536 | In distribution | |
| 70327006 | In distribution | |
| 70327000 | In distribution | |
| 70326505 | In distribution | |
| 70328002 | In distribution | |
| 70329035 | In distribution | |
| 70326535 | In distribution | |
| 70326100 | In distribution | |
| 70326541 | In distribution | |
| 70326111 | In distribution | |
| 70326537 | In distribution | |
| 70327007 | In distribution | |
| 70326503 | In distribution | |
| 70326127 | In distribution | |
| 70327037 | In distribution | |
| 70326126 | In distribution | |
| 70327039 | In distribution | |
| 70327011 | In distribution | |
| SB2940SC | In distribution | |
| 70326122 | In distribution | |
| 70326109 | In distribution | |
| 70327003 | In distribution | |
| 70326500 | In distribution | |
| 70326511 | In distribution | |
| 70326543 | In distribution | |
| 70329031 | In distribution | |
| 70326538 | In distribution | |
| 70329003 | In distribution | |
| 70328014 | In distribution | |
| 70327002 | In distribution | |
| 70327009 | In distribution | |
| 70328016 | In distribution | |
| 70326504 | In distribution | |
| 70326131 | In distribution | |
| 70326123 | In distribution | |
| 70322015 | In distribution | |
| 70326540 | In distribution | |
| 70326539 | In distribution | |
| 70327033 | In distribution | |
| 70328003 | In distribution | |
| 70328017 | In distribution | |
| 70329025 | In distribution | |
| 70326542 | In distribution | |
| 70326101 | In distribution | |
| 70322016 | In distribution | |
| 70326125 | In distribution | |
| 70326534 | In distribution | |
| 70327008 | In distribution | |
| 70329027 | In distribution | |
| 70322014 | In distribution | |
| 70328013 | In distribution | |
| 70326510 | In distribution | |
| 70326104 | In distribution | |
| 70326103 | In distribution | |
| 70326502 | In distribution | |
| 70326507 | In distribution | |
| 70326102 | In distribution | |
| 70328001 | In distribution | |
| 70326132 | In distribution | |
| 70328000 | In distribution | |
| 70326106 | In distribution | |
| 70326110 | In distribution | |
| 70329033 | In distribution | |
| 70329005 | In distribution | |
| 70329007 | In distribution | |
| BUR3015DB | In distribution | |
| 70329001 | In distribution | |
| 70326108 | In distribution | |
| 70326121 | In distribution | |
| 70326506 | In distribution | |
| 70327035 | In distribution | |
| 70327005 | In distribution | |
| 70327004 | In distribution | |
| 70326129 | In distribution | |
| 70327012 | In distribution | |
| 70327038 | In distribution | |
| 70328005 | In distribution | |
| 70326512 | In distribution | |
| 70326120 | In distribution | |
| 70326130 | In distribution | |
| 70327032 | In distribution | |
| 70329029 | In distribution | |
| 70326128 | In distribution | |
| 70326508 | In distribution | |
| 70326501 | In distribution | |
| 70327034 | In distribution | |
| 70326124 | In distribution | |
| 70326509 | In distribution | |
| 70329009 | In distribution | |
| 70322013 | In distribution | |
| 70328015 | In distribution | |
| 70326544 | In distribution | |
| 70327001 | In distribution | |
| 70326105 | In distribution | |
| 70329011 | In distribution | |
| 70326107 | In distribution | |
| 70327036 | In distribution | |
| 70328004 | In distribution | |
| 70327010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bur, Ear, Nose And Throat | Medtronic Xomed, Inc. | 413 |
| 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 |
| Medline | Medline Industries, Inc. | 36 |
| 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
Recalls
1 of these is 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 | Reason | Quantity |
|---|---|---|---|
| 2017-08-03 | Class II | “Chattering” when cutting burrs are used in bone. | 324 |
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.