Bur, Surgical, General & Plastic Surgery
2.0mm Long Tapered Side Cutting Solid Carbide Bur Medium
7manufacturers in China registered for this device type
95catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Zonefly Medical Devices Co., Ltd. | Danyang | Jiangsu | Specification developer | 7 |
| Jiangxi Vision Plus Medical Technology Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | GFF |
| Device type | Bur, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-23 |
| Record revised | 2025-07-07 (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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Length 48 to 95.3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0277010250 | Diameter: 5.0 Millimeter | In distribution |
| 5300010714 | Length 50.8 mm | In distribution |
| 5300010307 | Length 48.0 mm | In distribution |
| 1608002013 | Diameter: 4.7 Millimeter | In distribution |
| 5300010133 | Length 62.0 mm | In distribution |
| 5300010708 | Length 50.8 mm | In distribution |
| 0277010235 | Diameter: 3.5 Millimeter | In distribution |
| 1608002035 | Diameter: 4.0 Millimeter | In distribution |
| 1607002017 | Diameter: 7.0 Millimeter | In distribution |
| 5300020901 | Diameter: 4.0 Millimeter | In distribution |
| 0277010210 | Diameter: 1.0 Millimeter | In distribution |
| 0277010208 | Diameter: 3.0 Millimeter | In distribution |
| 1608006091 | Diameter: 3.0 Millimeter | In distribution |
| 5300010718 | Diameter: 2.1 Millimeter | In distribution |
| 6517070021 | In distribution | |
| 5300010509 | Diameter: 3.0 Millimeter | In distribution |
| 1608002009 | Diameter: 2.4 Millimeter | In distribution |
| 1607002003 | Diameter: 6.0 Millimeter | In distribution |
| 0277010212 | Diameter: 1.2 Millimeter | In distribution |
| 5300010516 | Diameter: 6.5 Millimeter | In distribution |
| 0277010216 | Diameter: 1.6 Millimeter | In distribution |
| 1608002001 | Diameter: 6.1 Millimeter | In distribution |
| 1608006087 | Diameter: 2.0 Millimeter | In distribution |
| 5820066016 | Diameter: 1.6 Millimeter | In distribution |
| 5300010903 | Length 48.0 mm | In distribution |
| 5300020505 | Length 73.2 mm | In distribution |
| 5820066232 | Diameter: 3.2 Millimeter | In distribution |
| 5300030511 | Length 95.3 mm | In distribution |
| 5300020511 | Diameter: 4.0 Millimeter | In distribution |
| 1900010040 | Diameter: 4.0 Millimeter | In distribution |
| 5300010505 | Diameter: 2.0 Millimeter | In distribution |
| 0277010221 | Diameter: 2.1 Millimeter | In distribution |
| 5300010071 | Length 50.8 mm | In distribution |
| 1360008000 | In distribution | |
| 5300010059 | Diameter: 1.1 Millimeter | In distribution |
| 6517040016 | In distribution | |
| 1608002021 | Diameter: 2.3 Millimeter | In distribution |
| 5300020515 | Diameter: 6.0 Millimeter | In distribution |
| 5300010063 | Diameter: 1.5 Millimeter | In distribution |
| 1608002043 | Diameter: 2.2 Millimeter | In distribution |
| 5300010704 | Length 50.8 mm | In distribution |
| 5300010503 | Diameter: 1.5 Millimeter | In distribution |
| 6517040012 | In distribution | |
| 5300030513 | Length 95.3 mm | In distribution |
| 0277010421 | Diameter: 2.1 Millimeter | In distribution |
| 5300010135 | Length 62.0 mm | In distribution |
| 1607002041 | Diameter: 8.0 Millimeter | In distribution |
| 5300010911 | Length 48.3 mm | In distribution |
| 1608006097 | Diameter: 4.5 Millimeter | In distribution |
| 1608010100S2 | Diameter: 4.9 Millimeter | In distribution |
| 5300010716 | Length 57.0 mm | In distribution |
| 1608002011 | Diameter: 3.2 Millimeter | In distribution |
| 1900015040 | Diameter: 4.0 Millimeter | In distribution |
| 5820066021 | Diameter: 2.1 Millimeter | In distribution |
| 5820066010 | Diameter: 1.0 Millimeter | In distribution |
| 1607002047 | Diameter: 6.0 Millimeter | In distribution |
| 5300010513 | Diameter: 5.0 Millimeter | In distribution |
| 1608010100S1 | Diameter: 4.8 Millimeter | In distribution |
| 5300030901 | Length 95.3 mm | In distribution |
| 1608006095 | Diameter: 4.0 Millimeter | In distribution |
| 0277010418 | Diameter: 1.8 Millimeter | In distribution |
| 6517048021 | In distribution | |
| 1608002005 | Diameter: 6.1 Millimeter | In distribution |
| 5300020903 | Diameter: 5.5 Millimeter | In distribution |
| 5300010421 | Diameter: 1.2 Millimeter | In distribution |
| 1608002135 | Diameter: 4.0 Millimeter | In distribution |
| 1607002035 | Diameter: 4.0 Millimeter | In distribution |
| 1608006083 | Diameter: 1.0 Millimeter | In distribution |
| 6517040010 | In distribution | |
| 1608006089 | Diameter: 2.5 Millimeter | In distribution |
| 1608002131 | Diameter: 2.0 Millimeter | In distribution |
| 5300010303 | Length 50.8 mm | In distribution |
| 1608006093 | Diameter: 3.5 Millimeter | In distribution |
| 5300010311 | Diameter: 6.0 Millimeter | In distribution |
| 0277010050 | Diameter: 5.0 Millimeter | In distribution |
| 5820066216 | Diameter: 1.6 Millimeter | In distribution |
| 1608002015 | Diameter: 6.0 Millimeter | In distribution |
| 1608002101 | Diameter: 2.1 Millimeter | In distribution |
| 1608002133 | Diameter: 3.0 Millimeter | In distribution |
| 1608006085 | Diameter: 1.5 Millimeter | In distribution |
| 1608002055 | Diameter: 4.0 Millimeter | In distribution |
| 1900015025 | Diameter: 2.5 Millimeter | In distribution |
| 5300010511 | Diameter: 4.0 Millimeter | In distribution |
| 5300010901 | Diameter: 4.0 Millimeter | In distribution |
| 5300010507 | Diameter: 2.4 Millimeter | In distribution |
| 0277010240 | Diameter: 4.0 Millimeter | In distribution |
| 5820066221 | Diameter: 2.1 Millimeter | In distribution |
| 1608002045 | Diameter: 1.5 Millimeter | In distribution |
| 5820066012 | Diameter: 1.2 Millimeter | In distribution |
| 5300020509 | Diameter: 3.0 Millimeter | In distribution |
| 5300010041 | Diameter: 1.6 Millimeter | In distribution |
| 0277010230 | Diameter: 3.0 Millimeter | In distribution |
| 1608006099 | Diameter: 5.0 Millimeter | In distribution |
| 5300010131 | Length 55.6 mm | In distribution |
| 5300020513 | Diameter: 5.0 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Komet Surgical Bur | Gebr. Brasseler Gmbh & Co. KG | 1,011 |
| Bur, Surgical, General & Plastic Surgery | Sterilmed, Inc. | 1,001 |
| Medline | Medline Industries, Inc. | 584 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 335 |
| Bur, Surgical, General & Plastic Surgery | Omega Surgical Instruments, Inc. | 312 |
| Bur, Surgical, General & Plastic Surgery | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 170 |
| MicroAire® | Microaire Surgical Instruments LLC | 162 |
| Ultrapower | ConMed Corporation | 155 |
| De Soutter Medical | DE Soutter Medical Ltd. | 143 |
| Jota | Jota AG | 112 |
| Conmed | ConMed Corporation | 109 |
| Bur, Round, round shank | Gebr. Brasseler Gmbh & Co. KG | 104 |
Showing 12 of 167. All products under Bur, Surgical, General & Plastic Surgery
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 |
|---|---|---|---|---|---|---|
| Stryker Instruments | UDI-DI | 2024-09-05 | Class II | Process control | May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be c | 307 units |
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.