HU-Friedy

Allen Orban Knife 1/2 Satin Steel Handle

Registry build 21.09.26
8manufacturers in China registered for this device type
80catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (2), Guangdong (2), Shanghai (1).

Chinese manufacturers registered for FDA product code EMF
Manufacturer City Province Registered as Device types
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Nanjing J SUN Healthcare Co., Ltd. Nanjing Jiangsu Repacker / relabeller 56
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Bothwin (Beijing) Medical Technology Co., Ltd. Beijng Beijing Manufacturer 25
Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 17
Foshan Cicada Dental Instrument Co., Ltd. Foshan Guangdong Manufacturer 15
Shenzhen Soga Technology Co., Ltd. Shenzhen Guangdong Manufacturer 7

Record

Regulatory record for HU-Friedy
Listed by HU-Friedy MFG Co., LLC, United States
FDA product code EMF
Device type Knife, Surgical
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-08-14
Record revised 2024-10-22 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number
Distribution end date 2024-05-08

Catalogue Numbers

Catalogue numbers for HU-Friedy
Catalogue number Size Status
TKN1 In distribution
KGF11X In distribution
KKN116 In distribution
KO12KPO3AR In distribution
TKN2S6 In distribution
KO1 In distribution
KO16 In distribution
KO12KP3R4X In distribution
KK15 In distribution
TKN1CH In distribution
FQUINCEY1X In distribution
KO12KPO3A6 In distribution
PPSPAHR6 In distribution
PPSPAHR In distribution
KO1/2X In distribution
KKN76 In distribution
KCK366 In distribution
KCK3 In distribution
KB3/46 In distribution
KK15/16S6 In distribution
KB3/4 In distribution
TKN2 In distribution
TKSTEIG In distribution
KGF11CH In distribution
PPSIC6 In distribution
TKN2CH In distribution
KPAX In distribution
KO26 In distribution
KK16 In distribution
KUSC6 In distribution
KK156 In distribution
TKSTEIG2 In distribution
KK15/166 In distribution
KK166 In distribution
KK15/169 In distribution
KPA In distribution
FQUINCEY2X In distribution
KGF96 In distribution
KO12KPO3A9 In distribution
KO12KPO3AX In distribution
KO1/29 In distribution
KO2 In distribution
FQUINCEY1 In distribution
FQUINCEY2 In distribution
KB5/66 In distribution
KO1/2KPA3 In distribution
KK15/16SX In distribution
KGF86 In distribution
KO21 In distribution
TKN1X In distribution
KSOLT1/26 In distribution
KO12KPO3R9 In distribution
KO12KPO3RX In distribution
TKN2SX In distribution
KGF116 In distribution
KGF7CH In distribution
KGF76 In distribution
KO12KP3R49 In distribution
TKN2X In distribution
KM3 In distribution
KK15/16X In distribution
KO1/26 In distribution
TKN1SX In distribution
KO22 In distribution
KM4 In distribution
KS1/26 In distribution
TKN1S6 In distribution
KB5/6 Withdrawn
KGF11 Withdrawn
KS1/2 Withdrawn
KPOL12 Withdrawn
KSOLT1/2 Withdrawn
KUSC Withdrawn
KO1/2 Withdrawn
KKN11 Withdrawn
KKN7 Withdrawn
KGF7 Withdrawn
KGF9 Withdrawn
KGF8 Withdrawn
KK15/16 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgistar Surgistar, Inc. 285
Surtex Surtex Instruments Ltd 189
Zoll-Dental Zoll-Dental 72
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 59
Lazic Peter Lazic Gmbh 47
Millennium Avalign Technologies, Inc. 40
Aesculap Aesculap AG 38
Sklar Sklar Corporation 35
Stylus Surgical Specialties México, S. de R.L. de C.V. 32
V. Mueller Steris Corporation 31
Elmed Elmed, Inc. 30
Gimmi Gimmi Gmbh 24

Showing 12 of 122. All products under Knife, Surgical

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