Zip 24 Surgical Skin Closure Device

Zip 24 Surgical Skin Closure Device, BSC

Registry build 21.09.26
353manufacturers in China registered for this device type
3catalogue numbers in this listing
3recalls on this code

Who Else Makes It

Concentrated in Zhejiang (101), Jiangsu (84), Guangdong (47). 40 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KGX
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Taizhou Xinkang Medical Materials Co., Ltd. Taizhou Jiangsu Contract manufacturer 35
Zhejiang Anji Huabu Industrial Co., Ltd. Huzhou Zhejiang Contract manufacturer 32
Shanghai Care Us Medical Product Co., Ltd. Shanghai Shanghai Contract manufacturer 30
Jinhua Jingdi Medical Supplies Co., Ltd. Jinhua Zhejiang Contract manufacturer 29
Nanjing 3H Medical Products Co., Ltd. Nanjing Jiangsu Contract manufacturer 25
Anji Hengfeng Sanitary Material Co., Ltd. Anji Zhejiang Contract manufacturer 20
Changzhou Recoo Healthcare Co., Ltd. Changzhou Jiangsu Contract manufacturer 19
Henso Medical (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Huizhou Foryou Medical Devices Co., Ltd. Huizhou Guangdong Contract manufacturer 18
Jianerkang Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 18

Showing 12 of 353. All 353 manufacturers in China registered for Tape And Bandage, Adhesive

Record

Regulatory record for Zip 24 Surgical Skin Closure Device
Listed by Zipline Medical, Inc., United States
FDA product code KGX
Device type Tape And Bandage, Adhesive
Device class Class 1
Regulation 21 CFR 880.5240
Premarket notification Exempt
Record published 2017-03-16
Record revised 2021-02-01 (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
Storage Special storage condition: Keep away from sunlight and heat. Keep dry.
Packaging Zip 24, 5-pack of 5, zip 24, 5-pack, bsc of 5
Sizes Length 24 cm
Distribution end date 2019-12-12

Catalogue Numbers

Catalogue numbers for Zip 24 Surgical Skin Closure Device
Catalogue number Size Status
667616001 Length 24 cm Withdrawn
PS1240 Length 24 cm Withdrawn
900024001 Length 24 cm Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Curad Medline Industries, Inc. 174
First Aid Only Acme United Corp. 130
CVS Health Woonsocket Prescription Center, Incorporated 120
American White Cross Dukal LLC 120
Avaline Medical NJ LLC Avaline Medical NJ Limited Liability Company 119
Howsport Jiaxing HOW Sport Medical Instrument Co., Ltd. 109
Endure Endure Industries, Inc. 71
TheraBand Kinesiology Tape Hygenic Corporation, THE 71
Dukal Dukal LLC 68
McKesson Mckesson Medical-Surgical Inc. 64
3M™ Steri-Strip™ 3M Company 59
3M™ Medipore™ 3M Company 58

Showing 12 of 966. All products under Tape And Bandage, Adhesive

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2015-02-05 Class II Packaging process control The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility. 3109 devices, total all model numbers 2015-04-10
2015-02-05 Class II Packaging process control The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility. 3109 – total – all model numbers 2015-04-10
2015-02-05 Class II Packaging process control The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility. 3109 total, all model numbers 2015-04-10

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