MicroAire®
Round Ball Cutter,diamond, Round Ball Cutter,diamond
7manufacturers in China registered for this device type
162catalogue 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 | Microaire Surgical Instruments LLC, United States |
|---|---|
| FDA product code | GFF |
| Device type | Bur, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-17 |
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, expiry date, manufacturing date |
| Sizes | Outer diameter 0.8 to 10.5 mm; length 2 to 15 mm |
| Distribution end date | 2021-12-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZB-73 | Outer Diameter 1.6 mm | In distribution |
| ZB-147 | Outer Diameter 1.1 mm | In distribution |
| ZB-164 | Outer Diameter 4 mm | In distribution |
| ZB-324 | Outer Diameter 2 mm | In distribution |
| ZB-220 | Outer Diameter 1 mm | In distribution |
| ZB-132 | Outer Diameter 6.5 mm | In distribution |
| ZB-180 | Outer Diameter 4 mm | In distribution |
| ZB-144 | Outer Diameter 4 mm | In distribution |
| ZB-292 | Outer Diameter 2.3 mm | In distribution |
| ZB-222 | Outer Diameter 1.5 mm | In distribution |
| ZB-326 | Outer Diameter 3 mm | In distribution |
| ZB-125 | Outer Diameter 2.4 mm | In distribution |
| ZB-182 | Outer Diameter 10.5 mm | In distribution |
| ZB-226 | Outer Diameter 3 mm | In distribution |
| ZB-268 | Outer Diameter 6 mm | In distribution |
| ZB-646 | Outer Diameter 3 mm | In distribution |
| ZB-113 | Outer Diameter 2 mm | In distribution |
| ZB-152 | Outer Diameter 2 mm | In distribution |
| ZB-328 | Outer Diameter 4 mm | In distribution |
| ZB-192 | Outer Diameter 2.3 mm | In distribution |
| ZB-628 | Outer Diameter 3 mm | In distribution |
| ZB-626 | Outer Diameter 5 mm | In distribution |
| ZB-664 | Outer Diameter 1 mm | In distribution |
| ZB-126 | Outer Diameter 3 mm | In distribution |
| ZB-448 | Outer Diameter 1.5 mm | In distribution |
| ZB-230 | Outer Diameter 5 mm | In distribution |
| ZB-330 | Outer Diameter 5 mm | In distribution |
| ZB-78 | Outer Diameter 2.1 mm | In distribution |
| ZB-71 | Outer Diameter 1.6 mm | In distribution |
| ZB-254 | Outer Diameter 4 mm | In distribution |
| ZB-160 | Outer Diameter 2 mm | In distribution |
| ZB-154 | Outer Diameter 4 mm | In distribution |
| ZB-619 | Outer Diameter 4 mm | In distribution |
| ZB-149 | Outer Diameter 2 mm | In distribution |
| ZB-662 | Outer Diameter 2 mm | In distribution |
| ZB-183 | Outer Diameter 10.2 mm | In distribution |
| ZB-103 | Outer Diameter 1 mm | In distribution |
| ZB-260 | Outer Diameter 2 mm | In distribution |
| ZB-238 | Outer Diameter 5.5 mm | In distribution |
| ZB-104 | Outer Diameter 1.5 mm | In distribution |
| ZB-362 | Outer Diameter 3 mm | In distribution |
| ZB-190 | Outer Diameter 1.9 mm | In distribution |
| ZB-102 | Outer Diameter 1.5 mm | In distribution |
| ZB-204 | Outer Diameter 1.5 mm | In distribution |
| ZB-203 | Outer Diameter 1.7 mm | In distribution |
| ZB-585 | Outer Diameter 8 mm | In distribution |
| ZB-336 | Outer Diameter 4 mm | In distribution |
| ZB-130 | Outer Diameter 5 mm | In distribution |
| ZB-627 | Outer Diameter 4 mm | In distribution |
| ZB-101 | Outer Diameter 1 mm | In distribution |
| ZB-236 | Outer Diameter 4 mm | In distribution |
| ZB-148 | Outer Diameter 1.5 mm | In distribution |
| ZB-121 | Outer Diameter 1 mm | In distribution |
| ZB-617 | Outer Diameter 6.5 mm | In distribution |
| ZB-618 | Outer Diameter 5 mm | In distribution |
| ZB-659 | Outer Diameter 3 mm | In distribution |
| ZB-658 | Outer Diameter 1 mm | In distribution |
| ZB-142 | Outer Diameter 2 mm | In distribution |
| ZB-645 | Outer Diameter 4 mm | In distribution |
| ZB-262 | Outer Diameter 3 mm | In distribution |
| ZB-306 | Outer Diameter 2 mm | In distribution |
| ZB-72 | Outer Diameter 1.2 mm | In distribution |
| ZB-75 | Outer Diameter 1.8 mm | In distribution |
| ZB-112 | Outer Diameter 2.3 mm | In distribution |
| ZB-264 | Outer Diameter 4 mm | In distribution |
| ZB-124 | Outer Diameter 2 mm | In distribution |
| ZB-650 | Outer Diameter 5 mm | In distribution |
| ZB-122 | Outer Diameter 1.5 mm | In distribution |
| ZB-114 | Outer Diameter 2 mm | In distribution |
| ZB-584 | Outer Diameter 7 mm | In distribution |
| ZB-366 | Outer Diameter 5 mm | In distribution |
| ZB-360S | Outer Diameter 2 mm | In distribution |
| ZB-228 | Outer Diameter 4 mm | In distribution |
| ZB-270 | Outer Diameter 4 mm | In distribution |
| ZB-266 | Outer Diameter 5 mm | In distribution |
| ZB-652 | Outer Diameter 4 mm | In distribution |
| ZB-586 | Outer Diameter 9 mm | In distribution |
| ZB-100 | Outer Diameter 0.8 mm | In distribution |
| ZB-145 | Outer Diameter 5 mm | In distribution |
| ZB-70 | Outer Diameter 2.3 mm | In distribution |
| ZB-232 | Outer Diameter 6.5 mm | In distribution |
| ZB-181 | Outer Diameter 7 mm | In distribution |
| ZB-252 | Outer Diameter 2 mm | In distribution |
| ZB-360 | Outer Diameter 2 mm | In distribution |
| ZB-128 | Outer Diameter 4 mm | In distribution |
| ZB-168 | Outer Diameter 6 mm | In distribution |
| ZB-77 | Outer Diameter 1.2 mm | In distribution |
| ZB-184 | Outer Diameter 5 mm | In distribution |
| ZB-200 | Outer Diameter 1.9 mm | In distribution |
| ZB-170 | Outer Diameter 4 mm | In distribution |
| ZB-206 | Outer Diameter 2 mm | In distribution |
| ZB-143 | Outer Diameter 3 mm | In distribution |
| ZB-214 | Outer Diameter 2 mm | In distribution |
| ZB-640 | Outer Diameter 1.5 mm | In distribution |
| ZB-224 | Outer Diameter 2 mm | In distribution |
| ZB-136 | Outer Diameter 4 mm | In distribution |
| ZB-76 | Outer Diameter 1.2 mm | In distribution |
| ZB-106 | Outer Diameter 2 mm | In distribution |
| ZB-364 | Outer Diameter 4 mm | In distribution |
| ZB-447 | Outer Diameter 1.1 mm | In distribution |
| ZB-74 | Outer Diameter 2.1 mm | In distribution |
| ZB-449 | Outer Diameter 2 mm | In distribution |
| ZB-138 | Outer Diameter 5.5 mm | In distribution |
| ZB-642 | Outer Diameter 2 mm | In distribution |
| ZB-338 | Outer Diameter 5.5 mm | In distribution |
| K-02 | Number of Flutes: 10 | Withdrawn |
| K-36 | Outer Diameter 6 mm | Withdrawn |
| K-52 | Outer Diameter 4 mm | Withdrawn |
| K-12 | Outer Diameter 4 mm | Withdrawn |
| K-17 | Outer Diameter 1.3 mm | Withdrawn |
| K-19 | Outer Diameter 2 mm | Withdrawn |
| K-35 | Outer Diameter 6 mm | Withdrawn |
| K-34 | Outer Diameter 6 mm | Withdrawn |
| K-48 | Outer Diameter 5 mm | Withdrawn |
| K-74 | Outer Diameter 2.1 mm | Withdrawn |
| K-28 | Outer Diameter 4 mm | Withdrawn |
| K-16 | Outer Diameter 1.1 mm | Withdrawn |
| K-50 | Outer Diameter 2.4 mm | Withdrawn |
| K-46 | Outer Diameter 4 mm | Withdrawn |
| K-71 | Outer Diameter 1.6 mm | Withdrawn |
| K-55 | Outer Diameter 4.8 mm | Withdrawn |
| K-32 | Outer Diameter 2.1 mm | Withdrawn |
| K-03 | Outer Diameter 6 mm | Withdrawn |
| K-09 | Outer Diameter 1.6 mm | Withdrawn |
| K-64 | Outer Diameter 3 mm | Withdrawn |
| K-40 | Outer Diameter 1 mm | Withdrawn |
| K-137 | Outer Diameter 4 mm | Withdrawn |
| K-65 | Outer Diameter 4 mm | Withdrawn |
| K-33 | Outer Diameter 6 mm | Withdrawn |
| K-27 | Outer Diameter 3 mm | Withdrawn |
| K-15 | Outer Diameter 7 mm | Withdrawn |
| K-78 | Outer Diameter 2.1 mm | Withdrawn |
| K-13 | Outer Diameter 4.7 mm | Withdrawn |
| K-44 | Outer Diameter 3 mm | Withdrawn |
| K-53 | Outer Diameter 4 mm | Withdrawn |
| K-57 | Outer Diameter 6.3 mm | Withdrawn |
| K-18 | Outer Diameter 1.6 mm | Withdrawn |
| K-47 | Outer Diameter 4.5 mm | Withdrawn |
| K-147 | Outer Diameter 2.4 mm | Withdrawn |
| K-01 | Outer Diameter 6 mm | Withdrawn |
| K-70 | Outer Diameter 2.3 mm | Withdrawn |
| K-77 | Outer Diameter 1.8 mm | Withdrawn |
| K-11 | Outer Diameter 3.1 mm | Withdrawn |
| K-75 | Outer Diameter 1.8 mm | Withdrawn |
| K-58 | Outer Diameter 6.3 mm | Withdrawn |
| K-73 | Outer Diameter 1.6 mm | Withdrawn |
| K-54 | Outer Diameter 4.8 mm | Withdrawn |
| K-51 | Outer Diameter 3.2 mm | Withdrawn |
| K-42 | Outer Diameter 2 mm | Withdrawn |
| K-14 | Outer Diameter 6 mm | Withdrawn |
| K-43 | Outer Diameter 2.5 mm | Withdrawn |
| K-22 | Outer Diameter 2.2 mm | Withdrawn |
| K-20 | Outer Diameter 3.2 mm | Withdrawn |
| K-45 | Outer Diameter 3.5 mm | Withdrawn |
| K-60 | Outer Diameter 1 mm | Withdrawn |
| K-72 | Outer Diameter 1.2 mm | Withdrawn |
| K-38 | Outer Diameter 4 mm | Withdrawn |
| K-26 | Outer Diameter 2 mm | Withdrawn |
| K-41 | Outer Diameter 1.5 mm | Withdrawn |
| K-08 | Outer Diameter 6 mm | Withdrawn |
| K-04 | Outer Diameter 6 mm | Withdrawn |
| K-62 | Outer Diameter 2 mm | Withdrawn |
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 |
| 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 |
| Stryker | Provision | 97 |
Showing 12 of 167. All products under Bur, Surgical, General & Plastic Surgery
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.