Silver Bullet®
Blade 1882905HRE Silver Bullet M4 2.9MM
5manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
3recalls on this code
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 | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | EQJ |
| Device type | Bur, Ear, Nose And Throat |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4140 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-01-19 |
| Record revised | 2024-05-23 (version 5) |
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 |
| Sizes | Length 11 cm; outer diameter 2.9 to 4 mm; outer diameter 2.9 cm |
| Distribution end date | 2023-12-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1884005HRE | Length 11.0 cm | In distribution | |
| 1884005HRE | Outer Diameter 4.0 mm | In distribution | |
| 1882905HRE | Length 11.0 cm | In distribution | |
| 1882905HRE | Length 11.0 cm | In distribution | |
| 1882905 | Outer Diameter 2.9 mm | 5 | Withdrawn |
| 1884005 | Length 11.0 cm | 5 | Withdrawn |
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 |
| Medline | Medline Industries, Inc. | 36 |
| Tricut® | Medtronic Xomed, Inc. | 31 |
Showing 12 of 646. All products under Bur, Ear, Nose And Throat
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K041985 | 2004-08-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic Xomed, Inc. | UDI-DI | 2021-08-31 | Class II | Process control | There was an increase in complaints related to tip breaks and wobble/vibration. | 274,991 total devices |
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 | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-07-05 | Class II | Under Investigation by firm | Product was distributed past expiration date. | 1 unit | |
| 2002-01-25 | Not classified | Other | Product packaging pouches may be open thereby compomising the sterile barrier. | 120 | 2012-07-13 |
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.