Ultimate Endo Retrieval Pouch

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

Registry build 21.09.26
4manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (2), Jiangsu (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KGY
Manufacturer City Province Registered as Device types
Zhejiang Aoki Medical Dressing Co., Ltd. Wenzhou Zhejiang Contract manufacturer 16
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
Xiamen JPL Industry & Trade Co., Ltd. Xiang An Area, Xiamen Fujian Manufacturer 2

Record

Regulatory record for Ultimate Endo retrieval pouch
Listed by Purple Surgical International Limited, United Kingdom
FDA product code KGY
Device type Bag, Intestine
Device class Class 1
Regulation 21 CFR 878.4100
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2016-09-17
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
Label carries lot or batch number, expiry date
Packaging Shipping carton of 50, shelf box of 5
Sizes Length 145 to 230 mm; width 90 to 190 mm; total volume 250 to 1150 ml

Catalogue Numbers

Catalogue numbers for Ultimate Endo retrieval pouch
Catalogue number Size Status
PS3444ULT Length 230 mm In distribution
PS3443ULT Length 180 mm In distribution
PS3442ULT Length 145 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
LapSac Cook Incorporated 12
Convertors Cardinal Health 200, LLC 5
LapSac Coopersurgical, Inc. 4
P&P Medical Surgical LLC P&P Medical Surgical LLC 4
Weck Teleflex Medical LLC 3
Alleset GRI Medical & Electronic Technology Co., Ltd. 2
3M™ Steri-Drape™ 3M Company 2
Secqure Ultimate Secqure Surgical, Corp. 2
Medline-Microtek Microtek Medical LLC 2
Cardinal Health Cardinal Health 200, LLC 1
Halyard Owens & Minor Distribution, Inc. 1
Cardinal Health Microtek Medical LLC 1

Showing 12 of 20. All products under Bag, Intestine

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