Bag, Intestine

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Zhejiang, Fujian and Jiangsu: 4 hold an FDA registration. 1 is a contract manufacturer.

Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
Xiamen JPL Industry & Trade Co., Ltd. Fujian
Zhejiang Aoki Medical Dressing Co., Ltd. Zhejiang, contract manufacturer
Zhejiang Mediunion Healthcare Group Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code KGY?

Bag, Intestine is FDA product code KGY, Class 1, 21 CFR 878.4100.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2015. None was by a company in China. The root cause the FDA records most often is Labeling Change Control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Secure Catch Tissue Retrieval Pouch Small With Tail Attachment

Catalogue number PS3405, listed by Purple Surgical International Limited, United Kingdom, under Bag, Intestine. 4 manufacturers in China are registered for this product code.

Secure Catch Tissue Retrieval Pouch Large

Catalogue number PS3404, listed by Purple Surgical International Limited, United Kingdom, under Bag, Intestine. 4 manufacturers in China are registered for this product code.

DeRoyal

Isolation Transport Bag

Secure Catch Tissue Retrieval Pouch Medium

Catalogue number PS3403, listed by Purple Surgical International Limited, United Kingdom, under Bag, Intestine. 4 manufacturers in China are registered for this product code.

Tissue Retrieval Pouch Large

The Tissue Retrieval Pouch is used during laparoscopic procedures for retrieving tissue specimens from the abdominal cavity.

Medline-Microtek

Isolation Bag, 46 cm x 47 cm (18 in x 18.5 in)

Secure Catch Tissue Retrieval Pouch Medium With Tail Attachment

The Purple Surgical Secure Catch Tissue Retrieval Pouch has applications in laparoscopic procedures for the safe, convenient removal of tissue specimens such as the appendix, gallbladder,…

Tissue Retrieval Pouch Small

The Tissue Retrieval Pouch is used during laparoscopic procedures for retrieving tissue specimens from the abdominal cavity.

Secure Catch Tissue Retrieval Pouch Small

Catalogue number PS3402, listed by Purple Surgical International Limited, United Kingdom, under Bag, Intestine. 4 manufacturers in China are registered for this product code.

P&P Medical Surgical LLC

Sterilization Pouches 3.5” x 5.25” Self-Sealing Autoclave Bags with Indicators for Professional Surgical Instrument Cleaning Box of 200

Secqure Ultimate

EndoRetrieval Pouch with 10mm Introducer & 130mm x 180mm Pouch

Cardinal Health

Isolation BAG 18X18.5IN Cardinal

Halyard

Equipment Cover Cover Clear Polyurethane 20IN x 20IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD

Convertors

Vi-Drape Isolation Bag

3m™ Steri-Drape™

3M™ Steri-Drape™ Isolation Bag, 10 per Carton / 4 Cartons per Case, 1003

Weck

Extraction bag, for 10 mm trocars

Cardinal Health

Personal Belonging Bag, Blue, Missouri Delta Medical, Non-sterile

Ultimate Endo Retrieval Pouch

The Ultimate Endo Retrieval Pouch is used during laparoscopic procedures for retrieving tissue specimens from the abdominal cavity.

LapSac

LapSac Surgical Tissue Pouch Yellow Drawstring

LapSac

LapSacTM Surgical Tissue Pouch (8”x10”)

Alleset

Isolation Bag Clear with Drawstring_20''X20''(50X50cm)_Non Sterile_100EA/CS

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