Getinge Pack Self-Seal Pouch

Self-Seal Pouch 13cm x 38cm

Registry build 21.09.26
19manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (7), Anhui (4), Hubei (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JOJ
Manufacturer City Province Registered as Device types
Hubei Qianjiang Kingphar Medical Material Co., Ltd. Qianjiang Hubei Contract manufacturer 52
Shanghai Jianzhong Medical Packaging Co., Ltd. Shanghai Shanghai Contract manufacturer 3
Dongguan Safesecure Medical Packaging Co., Ltd. Dongguan Guangdong Contract manufacturer 2
Jiangsu Jsongmed Medical Material Co., Ltd. Jiangsu Jiangsu Contract manufacturer 2
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Shanghai Hua En Industrial Co Ltd Shanghai Shanghai Contract manufacturer 52
Anqing Clean Dental Instrument Technology Co., Ltd. Anqing Anhui Manufacturer 50
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
Wellmed Dental Medical Supply Co., Ltd. Shenzhen Guangdong Manufacturer 37
Premium Plus (Dongguan) Limited Dongguan Guangdong Repacker / relabeller 34
Anhui Ares Medical Technology Co., Ltd. Tianchang Anhui Contract manufacturer 28
Bgss Company Asia Limited Zhabei Shanghai Contract manufacturer 25

Showing 12 of 19. All 19 manufacturers in China registered for Indicator, Physical/Chemical Sterilization Process

Record

Regulatory record for Getinge Pack Self-Seal Pouch
Listed by PMS Tibbi Cihazlar Teknolojisi Sanayi VE Ticaret Anonim Sirketi
FDA product code JOJ
Device type Indicator, Physical/Chemical Sterilization Process
Device class Class 2
Regulation 21 CFR 880.2800
510(k) K152669
Record published 2017-08-29
Record revised 2019-11-08 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment humidity up to 70 % RH; Storage environment temperature up to 35 °C
Packaging Case of 3, case of 6, case of 25, case, case of 14

Catalogue Numbers

Catalogue numbers for Getinge Pack Self-Seal Pouch
Catalogue number Size Per pack Status
GUKP1338 200 In distribution
GUKP2538 200 In distribution
GUKP3045 200 In distribution
GUKP0925 200 In distribution
GUKP3346 200 In distribution
GUKP2041 200 In distribution
GUKP1530 200 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hu-Friedy HU-Friedy MFG Co., LLC 32
JMU JMU Dental, Inc 32
MARK3 Cargus International, Inc 28
Comply™ 3M Company 25
Verify Albert Browne Ltd. 24
Cardinal Health Cardinal Health 200, LLC 19
Verify Steris Corporation 18
McKesson Mckesson Medical-Surgical Inc. 16
Sklar® Sklar Corporation 14
Case Medical Case Medical, Inc. 13
Dental City ICP, Inc. 13
PlastCare Proguard Health Inc. 12

Showing 12 of 278. All products under Indicator, Physical/Chemical Sterilization Process

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