Aesculap

EICKEN Irrigation Cannula, slightly curved, 5 3/4", (145 mm), diam. 2,50 mm, blunt, non-sterile, reusable

Registry build 21.09.26
27manufacturers in China registered for this device type
20catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (10), Zhejiang (6), Shanghai (3). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KAR
Manufacturer City Province Registered as Device types
Covidien Medical Products (Shanghai) Manufacturing LLC Shanghai Shanghai Contract manufacturer 8
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shandong Zhushi Pharmaceutical Group Co., Ltd. Heze Shandong Contract manufacturer 65
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Wenzhou Caretek Medical Device Co., Ltd. Wenzhou Zhejiang Contract manufacturer 30
Shenzhen Balinda Technology Co., Ltd. Shenzhen Guangdong Manufacturer 23
Xiamen Zhiyuan Medical Technology Co., Ltd. Xiamen Fujian Contract manufacturer 22
Aimi Health Technology (Guangdong) Co., Ltd. Dongguan Guangdong Manufacturer 21
Hebei Youjie Medical Devices Co., Ltd. Shijiazhuang Hebei Manufacturer 18
Dongguan Yipincheng Technology Co., Ltd. Dongguan Guangdong Manufacturer 17

Showing 12 of 27. All 27 manufacturers in China registered for Irrigator, Sinus

Record

Regulatory record for Aesculap
Listed by Aesculap AG, Germany
FDA product code KAR
Device type Irrigator, Sinus
Device class Class 1
Regulation 21 CFR 874.4420
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2020-06-20
Record revised 2021-10-04 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Aesculap
Catalogue number Size Status
MA990R In distribution
MB452ZR In distribution
MA525R In distribution
MA527R In distribution
MA528R In distribution
MB453ZR In distribution
OK876R In distribution
MG375R In distribution
MA529R In distribution
OK877R In distribution
MA530R In distribution
MA532R In distribution
MA531R In distribution
MD887 In distribution
MB451ZR In distribution
MA523R In distribution
MA526R In distribution
MB450ZR In distribution
MA524R In distribution
MA988R In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 18
Avalign Avalign Technologies, Inc. 15
Boss Instruments Boss Instruments, Ltd. 12
MSI Precision Specialty Instruments MED Saver, Inc. 10
Pilling Teleflex Medical LLC 10
AED National Advanced Endoscopy Devices, Inc. 5
GEN2 Surgix Medical LLC 4
Novo Surgical Inc. Novo Surgical, Inc. 4
Millennium Avalign Technologies, Inc. 4
InhwRior Shenzhen Yuechuan Trade Co., Ltd. 4
Cannula KLS-Martin L.P. 3
Symmetry House Aspen Surgical Products, Inc. 2

Showing 12 of 24. All products under Irrigator, Sinus

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