PMI

For Percutaneous Insertion, Combo Pack Includes:(PMIORCA20) Disposable Operative Cholangiogram Catheter 20" & (PIN-15) Disposable Percutaneous Introducer 4" length and 14 gauge

Registry build 21.09.26
1manufacturer
8catalogue numbers in this listing

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 PMI
Listed by Progressive Medical Technology, Inc., United States
FDA product code GBZ
Device type Catheter, Cholangiography
Device class Class 1
Regulation 21 CFR 878.4200
Premarket notification Exempt
Record published 2016-09-23
Record revised 2022-10-10 (version 5)

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, manufacturing date
Packaging Box of 10, box of 6
Distribution end date 2017-08-01

Catalogue Numbers

Catalogue numbers for PMI
Catalogue number Size Status
PMIXL11 In distribution
PMILAP13 In distribution
PMICATH20 In distribution
PMIXLPIN In distribution
PMIORCA In distribution
PMIORCB In distribution
PMIXLPIN Withdrawn
PMIORCAP20 Withdrawn

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
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
Petelin Cook Incorporated 1

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