Reveal

The Reveal distal attachment cap is attached to the distal end of the endoscope to facilitate endoscopic therapy. The Reveal distal attachment cap is intended for the following:…

Registry build 21.09.26

The Reveal distal attachment cap is attached to the distal end of the endoscope to facilitate endoscopic therapy. The Reveal distal attachment cap is intended for the following: gastrointestinal mucosal resection (endoscopic mucosal resection) and keeping the suitable depth of endoscope’s view field.

10manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Zhejiang (3), Chongqing (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OCX
Manufacturer City Province Registered as Device types
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Smartdata Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 11
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Jiana Sterilization Technology (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 23
Hangzhou AGS MedTech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 19
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. Changzhou Jiangsu Manufacturer 14
Changzhou Endoclean Medical Device Co., Ltd. Changzhou Jiangsu Repacker / relabeller 13
Chongqing Jinshan Science & Technology (Group) Co., Ltd. Chongqing Chongqing Manufacturer 4

Record

Regulatory record for Reveal
Listed by Us Endoscopy, United States
FDA product code OCX
Device type Endoscopic Irrigation/Suction System
Device class Class 2
Regulation 21 CFR 876.1500
Record published 2020-04-01
Record revised 2021-04-07 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Storage Special storage condition: Keep Dry
Packaging Box of 10, case of 10
Sizes Outer diameter 11 to 16 mm
Distribution end date 2020-03-31

Catalogue Numbers

Catalogue numbers for Reveal
Catalogue number Size Status
00711775 Outer Diameter 16 mm In distribution
00711770 Outer Diameter 11 mm In distribution
00711773 Outer Diameter 13 mm In distribution
00711772 Outer Diameter 12 mm In distribution
00711771 Outer Diameter 12 mm In distribution
00711774 Outer Diameter 15 mm In distribution
00711771 Outer Diameter 12 mm Withdrawn
00711775 Outer Diameter 16 mm Withdrawn
00711770 Outer Diameter 11 mm Withdrawn
00711773 Outer Diameter 13 mm Withdrawn
00711772 Outer Diameter 12 mm Withdrawn
00711774 Outer Diameter 15 mm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Endogator Kit Medivators Inc 37
Clean Connecting Tube Yangzhou Fartley Medical Instrument Technology Co., Ltd. 21
Erbe Erbe Elektromedizin GmbH 19
Endogator Medivators Inc 18
Torrent Us Endoscopy 14
ClearCap Distal Attachment Finemedix 14
EndoGator Hybrid Medivators Inc 13
Endoscopic Irrigation/Suction System Pentax of America, Inc. 12
Endogator hybrid irrigation tubing Medivators Inc 10
Erbeflo® 2 Erbe Medical, LLC 9
BullDog® Diversatek Healthcare Inc 9
Olympus Keymed (Medical & Industrial Equipment) Ltd 8

Showing 12 of 123. All products under Endoscopic Irrigation/Suction System

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