Backflush Instrument With Brush needle.(20 Gauge / 0.9 Mm)

Catalogue number 1281.B, listed by D.o.r.c. Dutch Ophthalmic Research Center (International) B.V., Netherlands, under Needle, Aspiration And Injection, Reusable. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (3), Jiangsu (2), Shandong (1).

Chinese manufacturers registered for FDA product code GDM
Manufacturer City Province Registered as Device types
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Anhui JM Healthcare Products Co., Ltd. Shouxian Anhui Manufacturer 25
Hangzhou Endo Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Wenzhou Aochang Misawa Medical Tech. Co., Ltd. Wenzhou Zhejiang Manufacturer 4
Zhenjiang Dingfeng Needle Manufacturing Technology Co., Ltd. Zhenjiang Jiangsu Contract manufacturer 1

Record

Regulatory record for Backflush instrument with brush needle.(20 gauge / 0.9 mm)
Listed by D.o.r.c. Dutch Ophthalmic Research Center (International) B.V., Netherlands
FDA product code GDM
Device type Needle, Aspiration And Injection, Reusable
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2021-02-01
Record revised 2021-02-22 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries manufacturing date

Catalogue Numbers

Catalogue numbers for Backflush instrument with brush needle.(20 gauge / 0.9 mm)
Catalogue number Size Status
1281.B In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medco Manufacturing Medco Manufacturing LLC 170
Millennium Avalign Technologies, Inc. 53
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MSI Precision Specialty Instruments MED Saver, Inc. 35
Pilling Teleflex Medical LLC 31
Breast Localization Needles Argon Medical Devices, Inc. 27
Tri-Port Cannula Möller Medical GmbH 20
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 19
Multi-Hole Cannula Möller Medical GmbH 18
MicroFrance® Integra Microfrance SAS 18
Rapid Extraction Cannula Möller Medical GmbH 16
Candy Cane Cannula Möller Medical GmbH 16

Showing 12 of 92. All products under Needle, Aspiration And Injection, Reusable

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