Komet Surgical Bur

1,011 catalogue numbers from NC0619.011..M0, listed by Gebr. Brasseler Gmbh & Co. KG, Germany, under Bur, Surgical, General & Plastic Surgery. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
1,011catalogue 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 Komet Surgical Bur
Listed by Gebr. Brasseler Gmbh & Co. KG, Germany
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, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-01-31

Specifications

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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Komet Surgical Bur
Catalogue number Size Per pack Status
NC0619.011..M0 In distribution
NC0106.012..K2 In distribution
NS0153.009..K2 In distribution
ND0135.012..M0 In distribution
NS0150.026..K2 In distribution
NC0187.009..K2 In distribution
NS1101.015..K2 In distribution
H162A.314.016.A1 In distribution
H255E.314.012.A2 5 In distribution
NS1604.007..K2 In distribution
H162ST.104.016.A1 In distribution
NS0126.016..M0 In distribution
NC0188.004..M0 In distribution
NS0125.006..M0 In distribution
NS1805.016..K2 In distribution
ND0132.009..M0 In distribution
D01104.009..K2 In distribution
ND0141.009..M0 In distribution
NC0105.004..K2 In distribution
H33R.316.016.G1 5 In distribution
NC0609.004..M0 In distribution
NC0905.003..A1 In distribution
NS0156.016..K2 In distribution
NC0110.004..M0 In distribution
NC0608.014..M0 In distribution
NS0152.006..M0 In distribution
ND0145.009..M0 In distribution
NS0120.016..K2 In distribution
NC0104.012..M0 In distribution
ND0147.012..M0 In distribution
NS0103.016..M0 In distribution
H1.316.010.AU 5 In distribution
NC0193.009..M0 In distribution
DS01102.009..M0 In distribution
NC0619.011..K2 In distribution
NS1703.018..M0 In distribution
NS1704.004..K2 In distribution
NS0151.009..M0 In distribution
NC0193.012..M0 In distribution
D01104.026..M0 In distribution
NC0608.027..M0 In distribution
NC0901.003..G1 5 In distribution
H33R.316.016.AU 5 In distribution
NS0154.012..K2 In distribution
ND0130.016..M0 In distribution
NC01165.009..K2 In distribution
NC0609.004..K2 In distribution
NS1701.004..M0 In distribution
NC0155.009..M0 In distribution
ND0147.006..M0 In distribution
ND0178.009..K2 In distribution
ND0139.026..M0 In distribution
D01100.009..K2 In distribution
NS1701.026..M0 In distribution
H141.316.010.AU 5 In distribution
NS1604.007..M0 In distribution
NC0306.010..K2 In distribution
H31.316.010.G1 5 In distribution
NS0109.016..M0 In distribution
NC0106.014..K2 In distribution
ND0135.012..K2 In distribution
NC1804.002..K2 In distribution
H141.105.018.A2 5 In distribution
NC0101.009..K2 In distribution
NC0106.004..K2 In distribution
D01107.026..M0 In distribution
H1.310.018.A2 5 In distribution
ND0179.009..K2 In distribution
NC1805.009..K2 In distribution
H255E.314.012.A1 In distribution
ND0140.009..K2 In distribution
H141.106.023.A2 5 In distribution
NS2205.009..M0 In distribution
NS1703.027..K2 In distribution
NS0115.006..M0 In distribution
NC0901.003..A1 In distribution
ND0146.026..M0 In distribution
H141.206.023.A2 5 In distribution
NC0107.004..M0 In distribution
D01106.009..K2 In distribution
NS0125.016..M0 In distribution
H255E.316.012.A1 In distribution
NC0303.004..M0 In distribution
NC0110.014..M0 In distribution
H33S.310.016.A2 5 In distribution
NS0150.006..M0 In distribution
NS0909.016..M0 In distribution
NC0193.012..K2 In distribution
NS0107.016..K2 In distribution
H141.104.027.A2 5 In distribution
NC0107.014..K2 In distribution
ND0135.006..K2 In distribution
NC0105.009..K2 In distribution
NC0194.009..K2 In distribution
H23.316.012.A2 5 In distribution
NS0120.026..M0 In distribution
NS1703.026..M0 In distribution
H31.316.012.A2 5 In distribution
H33L.320.021.A2 5 In distribution
NC0195.026..K2 In distribution
ND0144.012..K2 In distribution
D01107.006..K2 In distribution
NC0302.004..M0 In distribution
NS0156.006..M0 In distribution
NC0612.004..M0 In distribution
NS0191.026..K2 In distribution
S2728.098..K1 In distribution
H33.316.016.A2 5 In distribution
NS4001.027..M2 In distribution
NS0123.016..M0 In distribution
D01105.006..M0 In distribution
D01102.026..M0 In distribution
NC0110.004..K2 In distribution
NC0901.003..M0 In distribution
NS1602.007..M0 In distribution
NC0196.009..M0 In distribution
NS2203.009..M0 In distribution
NS1808.022..M0 In distribution
NC0193.009..K2 In distribution
NS1809.027..M0 In distribution
H33.320.016.A2 5 In distribution
NC0607.004..K2 In distribution
NC0901.003..K2 In distribution
NC0125.009..K2 In distribution
NC0125.012..K2 In distribution
ND0146.012..M0 In distribution
NS0150.026..M0 In distribution
NS0115.006..K2 In distribution
D01104.026..K2 In distribution
NS3501.027..K2 In distribution
D01100.009..M0 In distribution
NS0407.026..M0 In distribution
ND0911.009..M0 In distribution
ND1903.004..K2 In distribution
H255E.316.012.A2 5 In distribution
NC0109.014..K2 In distribution
ND0129.012..K2 In distribution
NS0101.009..M0 In distribution
NC0613.009..K2 In distribution
NS4101.009..K2 In distribution
ND0445.009..K2 In distribution
NC0608.009..M0 In distribution
SC2802.098..M0 In distribution
NS2201.009..M0 In distribution
NS0151.006..K2 In distribution
NS0154.009..M0 In distribution
NC0306.010..M0 In distribution
NS0115.012..K2 In distribution
NS0153.012..M0 In distribution
NS0407.009..M0 In distribution
NS3701.027..M2 In distribution
NS0156.009..K2 In distribution
H33L.316.012.A2 5 In distribution
ND0145.009..K2 In distribution
S2730.501..M0 In distribution
H31.316.010.A1 In distribution
NS3501.005..M0 In distribution
NC0306.004..K2 In distribution
ND0173.009..K2 In distribution
D01101.006..K2 In distribution
NC0606.004..M0 In distribution
D01106.012..K2 In distribution
NS1701.012..M0 In distribution
NC0189.009..M0 In distribution
NS1601.006..M0 In distribution
ND0141.009..K2 In distribution
H33L.105.012.A2 5 In distribution
NS0153.006..M0 In distribution
NC0306.004..M0 In distribution
D01107.012..M0 In distribution
H48L.310.014.A2 5 In distribution
NS0155.026..M0 In distribution
NS0125.009..M0 In distribution
NC0107.004..K2 In distribution
D01100.012..M0 In distribution
NC01164.009..K2 In distribution
D01101.009..M0 In distribution
NC0905.003..M0 In distribution
NS3703.036..M2 In distribution
H1.316.006.AU 5 In distribution
NC0117.009..M0 In distribution
NS2203.009..K2 In distribution
NS1809.027..K2 In distribution
D01104.009..M0 In distribution
ND0137.016..K2 In distribution
NC0190.009..K2 In distribution
NS1701.027..M0 In distribution
H31.316.016.A2 5 In distribution
NS1202.009..M0 In distribution
NC0106.009..M0 In distribution
NS1204.009..M0 In distribution
NC0103.012..M0 In distribution
H141.320.023.A2 5 In distribution
ND0142.026..M0 In distribution
H33.316.012.A2 5 In distribution
NS4101.009..M2 In distribution
S2731.501..K1 In distribution
S2723.098..M0 In distribution
NC0170.009..M0 In distribution
ND0141.026..M0 In distribution
D01102.006..K2 In distribution
S27247.098..K1 In distribution
NC0186.016..M0 In distribution
NS0125.014..M0 In distribution
ND0136.009..K2 In distribution
D01107.026..K2 In distribution
H141.320.018.A2 5 In distribution
NS1704.004..M0 In distribution
S2737.502..M0 In distribution
NC0307.004..K2 In distribution
NC0606.014..A2 5 In distribution
H031RS.316.010.A2 5 In distribution
H33.316.016.AU 5 In distribution
NC0103.009..K2 In distribution
H41.316.023.A2 5 In distribution
NC0104.012..K2 In distribution
NS0123.026..K2 In distribution
NC0104.004..A1 In distribution
D01108.012..K2 In distribution
H33.316.012.G1 5 In distribution
H1.316.014.A6 100 In distribution
NS0101.009..K2 In distribution
NC0108.014..K2 In distribution
NC0901.014..M0 In distribution
DM01102.026..M0 In distribution
ND0190.006..M0 In distribution
NS2204.009..M0 In distribution
NS0152.009..K2 In distribution
H31.316.014.A2 5 In distribution
NC0196.009..K2 In distribution
NC0155.012..K2 In distribution
NC0106.014..M0 In distribution
NC0108.014..M0 In distribution
NS0191.009..M0 In distribution
NC1810.027..M0 In distribution
ND0128.026..M0 In distribution
D01106.009..M0 In distribution
NC1806.027..M0 In distribution
NC0109.012..M0 In distribution
ND0147.026..K2 In distribution
H23L.316.009.A2 5 In distribution
H33L.316.012.G1 5 In distribution
NS3801.005..K2 In distribution
NC0103.004..K2 In distribution
NS0409.009..K2 In distribution
ND0133.009..K2 In distribution
H1.316.016.A2 5 In distribution
NC0327.002..K2 In distribution
H1.206.014.A2 5 In distribution
NS3604.027..M0 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
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