What is FDA product code FDF?

To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Gastroenterology & Urology › DiagnosticColonoscope And Accessories, Flexible/Rigid

Defendo Disposable Suction and Biopsy Valve Kit

Name: Defendo Disposable Suction and Biopsy Valve Kit
Brand: Defendo Disposable Suction and Biopsy Valve Kit

Catalogue number 100320, listed by Medivators Inc, United States, under Colonoscope And Accessories, Flexible/Rigid. 9 manufacturers in China are registered for this product code.

Registry build 21.09.26

9manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shanghai (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FDF
Manufacturer	City	Province	Registered as	Device types
Dalian Create Medical Products Co., Ltd.	Dalian	Liaoning	Contract manufacturer	2
Yangzhou Fartley Medical Instrument Technology Co., Ltd.	Yangzhou	Jiangsu	Contract manufacturer	24
Alton Shanghai Medical Instruments Co Ltd	Shanghai	Shanghai	Complaint-file establishment	20
Hangzhou AGS MedTech Co., Ltd.	Hangzhou	Zhejiang	Repacker / relabeller	19
BQ Plus Medical Co., Ltd.	Songjiang	Shanghai	Contract manufacturer	13
Guangzhou RED Pine Medical Instrument Co., Ltd.	Guangzhou	Guangdong	Manufacturer	8
Sonoscape Medical Corp.	Shenzhen	Guangdong	Manufacturer	7
Shanghai Seegen Photoelectric Technology Co., Ltd.	Shanghai	Shanghai	Manufacturer	7
Daichuan Medical (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Manufacturer	2

Record

Regulatory record for Defendo Disposable Suction and Biopsy Valve Kit
Listed by	Medivators Inc, United States
FDA product code	FDF
Device type	Colonoscope And Accessories, Flexible/Rigid
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2024-07-25 (version 9)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2022-05-25

Catalogue Numbers

Catalogue numbers for Defendo Disposable Suction and Biopsy Valve Kit
Catalogue number	Size	Status
100320		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Fuse	Endochoice, Inc.	52
Colonoscope And Accessories, Flexible/Rigid	Karl Storz GmbH & Co. KG	51
Fujifilm	Fujifilm Corporation	40
Pentax	Hoya Corporation	37
Video Colonoscope	Pentax of America, Inc.	25
G-EYE Colonoscope	Smart Medical Systems Ltd.	24
Medisono	Medisono, LLC	18
Evis Exera lll Colonovideoscope	Olympus Medical Systems Corp.	16
Endoch	Endoch Inc	14
Evis Exera II Colonovideoscope	Olympus Medical Systems Corp.	12
Colonovideoscope	Olympus Medical Systems Corp.	12
Colonoscope And Accessories, Flexible/Rigid	Hangzhou AGS MedTech Co., Ltd.	10

Showing 12 of 115. All products under Colonoscope And Accessories, Flexible/Rigid

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.