Bur, Surgical, General & Plastic Surgery

2.1 MM X 2.35 MM X 60.0 MM Tapered Long Round Side Cutting Carbide BUR With O Notch, 6 Flute NON Sterile

Registry build 21.09.26
7manufacturers in China registered for this device type
312catalogue 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.

Chinese manufacturers registered for FDA product code GFF
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

Regulatory record for Bur, Surgical, General & Plastic Surgery
Listed by Omega Surgical Instruments, Inc., 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, Manufacturer
Premarket notification Exempt
Record published 2022-06-01
Record revised 2024-04-24 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Bur, Surgical, General & Plastic Surgery
Catalogue number Size Status
A2070 In distribution
S557-51N In distribution
H-262 In distribution
MR10BA50 In distribution
S3770 In distribution
R2-51N In distribution
S1558-51 In distribution
MR14BA60 In distribution
R6070 In distribution
R4070 In distribution
H-338 In distribution
ZO-650 In distribution
MR10BA30 In distribution
S703-60-01NS In distribution
S560-51 In distribution
H-183 In distribution
MR15BA40 In distribution
H-424 In distribution
H-326 In distribution
H-366 In distribution
R4070N In distribution
R1870N In distribution
L1670 In distribution
S702L-51 In distribution
H-125 In distribution
SH206512 In distribution
R1070N In distribution
H-236 In distribution
H-158 In distribution
H-320 In distribution
MR9BA30 In distribution
D1070N In distribution
D1570 In distribution
H-420 In distribution
D2070N In distribution
R3570N In distribution
H-124 In distribution
ZO-680 In distribution
ZO-666 In distribution
H-128 In distribution
S703-51N In distribution
R3-51N In distribution
MR10BA50D In distribution
A3070N In distribution
H-206 In distribution
ZO-616 In distribution
ZO-619 In distribution
R1570N In distribution
R2370N In distribution
MR10BA20 In distribution
MR9AC75 In distribution
H-120 In distribution
ZO-678 In distribution
ZO-652 In distribution
R3570 In distribution
ZO-642 In distribution
R60-51N In distribution
R2770N In distribution
D2570N In distribution
H-164 In distribution
ZO-681 In distribution
SH206508 In distribution
ES-071-058 In distribution
MR8TA11 In distribution
H-268 In distribution
H-328 In distribution
ZO-643 In distribution
A1070N In distribution
R3070 In distribution
R8-51N In distribution
X-21555 In distribution
X-21569 In distribution
ZO-667 In distribution
D4570N In distribution
R8-51 In distribution
S560-51N In distribution
S701-51N In distribution
D7070N In distribution
H-204 In distribution
H-152 In distribution
H-154 In distribution
X-27656 In distribution
S701-51 In distribution
H-264 In distribution
H-266 In distribution
ES-BA140 In distribution
O40-65-01NS In distribution
H-144 In distribution
X-27652 In distribution
HC-185 In distribution
ROPS2020 In distribution
R40-51N In distribution
MR9BA60 In distribution
R2070N In distribution
H-170 In distribution
H-168 In distribution
X-21560 In distribution
X-21565 In distribution
H-402 In distribution
HC-184 In distribution
ZO-679 In distribution
R8-60-01NS In distribution
H-260 In distribution
D3570 In distribution
ZO-645 In distribution
ZO-628 In distribution
H-104 In distribution
ZO-647 In distribution
H-230S In distribution
X-27657 In distribution
ZO-686 In distribution
S3070 In distribution
S703L-51N In distribution
R7070N In distribution
ZO-644 In distribution
H-162 In distribution
R5070 In distribution
ZO-663 In distribution
S700-51 In distribution
X-27653 In distribution
A6070N In distribution
D2070 In distribution
ZO-674 In distribution
ZO-664 In distribution
MR9BA40D In distribution
H-101 In distribution
L1670N In distribution
O4070 In distribution
A4070N In distribution
ZO-665 In distribution
H-102 In distribution
H-232 In distribution
S702-60-01NS In distribution
R6070N In distribution
H-324 In distribution
H-114 In distribution
H-325 In distribution
R3-51 In distribution
D4070N In distribution
A1070 In distribution
MR10BA30D In distribution
MR10BA60 In distribution
ZO-660 In distribution
ZO-677 In distribution
H-143 In distribution
H-226 In distribution
D3070 In distribution
S703L-51 In distribution
H-330 In distribution
R8-44N In distribution
ROPS2060 In distribution
S699-51 In distribution
H-166 In distribution
MR14BA30D In distribution
H-233S In distribution
MR10BA40 In distribution
H-368 In distribution
MR14BA50 In distribution
S1703L-60-01NS In distribution
ZO-659 In distribution
ZO-662 In distribution
MR9BA30D In distribution
R4570N In distribution
D4570 In distribution
H-364 In distribution
MR10MH30 In distribution
H-360 In distribution
S3370 In distribution
R2070 In distribution
S1703L-51N In distribution
H-422 In distribution
ROPS2030 In distribution
H-336 In distribution
S5070N In distribution
O4035N In distribution
B6070N In distribution
H-122 In distribution
X-21570 In distribution
X-27655 In distribution
MR15BA50 In distribution
S4070 In distribution
R7070 In distribution
H-231S In distribution
H-406 In distribution
ZO-649 In distribution
MR14BA30 In distribution
D5070N In distribution
ZO-685 In distribution
H-258 In distribution
H-224 In distribution
H-222 In distribution
H-214 In distribution
D6070N In distribution
ZO-626 In distribution
B6070 In distribution
ROPS2050 In distribution
H-252 In distribution
S2070 In distribution
S1703L-51 In distribution
ZO-627 In distribution
S1703-60-01NS In distribution
H-401 In distribution
ZO-625 In distribution
R3070N In distribution
S700-51N In distribution
H-136 In distribution
S3070N In distribution
D2570 In distribution
H-160 In distribution
S699-51N In distribution
H-232S In distribution
R6-60-01NS In distribution
A2070N In distribution
ES-MH30 In distribution
MR14MH30 In distribution
X-27654 In distribution
H-332 In distribution
ZO-668 In distribution
H-362 In distribution
A4070 In distribution
S703-51 In distribution
D6070 In distribution
HC-186 In distribution
D5070 In distribution
H-230 In distribution
MR14BA40D In distribution
H-254 In distribution
H-203 In distribution
R6-51 In distribution
S557-51 In distribution
R4570 In distribution
ZO-646 In distribution
S701-60-01NS In distribution
H-106 In distribution
H-180 In distribution
ZO-618 In distribution
MR14BA40 In distribution
MR10BA40D In distribution
R5070N In distribution
R6-51N In distribution
H-270 In distribution
R60-51 In distribution
R1070 In distribution
R50-51N In distribution
MR10BA20D In distribution
H-403 In distribution
S5070 In distribution
H-142 In distribution
O4070N In distribution
ZO-648 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA 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 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
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer