Aesculap

Brain Spatula, 6 1/8", (155 mm), working length: , 4", (100 mm), diam. 3,50 mm, round, malleable, width: 17 mm, non-sterile, reusable

Registry build 21.09.26
12manufacturers in China registered for this device type
59catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (3), Hebei (3), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GAF
Manufacturer City Province Registered as Device types
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Cangzhou Lankang Medical Instruments Developing Co., Ltd. Cangzhou Hebei Manufacturer 40
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Huanghua DK Dental Co., Ltd. Huanghua Hebei Manufacturer 37
Guangdong Xinuo Personal Care Products Co., Ltd. Yunfu Guangdong Manufacturer 33
Hangzhou Haizhu MIM Products Co., Ltd. Hangzhou Zhejiang Exporter 28
Shanghai Lange Medtech Co., Ltd. Shanghai Shanghai Manufacturer 16

Record

Regulatory record for Aesculap
Listed by Aesculap AG, Germany
FDA product code GAF
Device type Spatula, Surgical, General & Plastic Surgery
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 2020-05-06
Record revised 2023-08-25 (version 3)

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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aesculap
Catalogue number Size Per pack Status
FF259R In distribution
BV928R In distribution
FD333R In distribution
FF446R In distribution
FF443R In distribution
FF256R In distribution
FB124R In distribution
BT742R In distribution
BT749R In distribution
BT750R In distribution
FF486R 10 In distribution
BT552R In distribution
BT553R In distribution
FF216R In distribution
FF442R In distribution
FF201R In distribution
FF212R In distribution
BT732R In distribution
BT560R In distribution
FF488R 10 In distribution
FF258R In distribution
FF213R In distribution
FF484R 10 In distribution
BT966R In distribution
FF233R In distribution
FF217R In distribution
FF231R In distribution
BV953R In distribution
FB150R In distribution
FF211R In distribution
BT551R In distribution
BT775R In distribution
BT740R In distribution
FF482R 10 In distribution
BT730R In distribution
MB063R In distribution
FF444R In distribution
FF232R In distribution
FF222R In distribution
BT777R In distribution
BN184R In distribution
FF302R In distribution
BT774R In distribution
MG728R In distribution
FF202R In distribution
FF445R In distribution
MD498 In distribution
FF300R In distribution
BT747R In distribution
FF441R In distribution
FF257R In distribution
FF480R 10 In distribution
FB151R In distribution
FF214R In distribution
BT776R In distribution
BT559R In distribution
BT746R In distribution
BT773R In distribution
BT561R In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Surgical Direct Surgical Direct, Inc. 131
HU-Friedy HU-Friedy MFG Co., LLC 84
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 45
GEN2 Surgix Medical LLC 34
Lazic Peter Lazic Gmbh 33
Fisherbrand Fisher Scientific Company L.L.C. 31
Sklar Sklar Corporation 29
Darby Dental Supply, LLC Darby Dental Supply, LLC 22
Spatula, Surgical, General & Plastic Surgery Fehling Instruments GmbH 21
Symmetry Davis Aspen Surgical Products, Inc. 19
Spatula KLS-Martin L.P. 19
Henry Schein Henry Schein, Inc. 18

Showing 12 of 93. All products under Spatula, 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