Oper Cholangiography Catheter

Oper Cholangiography Catheter ORC Type B PN 68010-01M

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GBZ
Manufacturer City Province Registered as Device types
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13

Record

Regulatory record for Oper Cholangiography Catheter
Listed by Ranfac Corp., United States
FDA product code GBZ
Device type Catheter, Cholangiography
Device class Class 1
Regulation 21 CFR 878.4200
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2017-05-04
Record revised 2018-03-29 (version 2)

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
Packaging Case of 8, inner pack of 10

Catalogue Numbers

Catalogue numbers for Oper Cholangiography Catheter
Catalogue number Size Status
18 GAUGE X 7″ 18 GAUGE x 7″ In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Taut Teleflex Medical LLC 31
PVC Thoracic Catheters Atrium Medical Corporation 30
Cook Cook Incorporated 12
Reddick Scoop Tip Cholangiogram Catheter Lemaitre Vascular, Inc. 8
Symmetry Surgical Aspen Surgical Products, Inc. 8
PMI Progressive Medical Technology, Inc. 8
Reddick Cholangiogram Catheter Lemaitre Vascular, Inc. 7
Olsen Cook Incorporated 7
Princeton Princeton Medical Group, Inc. 3
RX Ercp Cannula Boston Scientific Corporation 2
Metal Catheter RZ Medizintechnik Gmbh 2
Catheter, Cholangiography Edwards Lifesciences Technology Sarl 2

Showing 12 of 32. All products under Catheter, Cholangiography

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