Splatter-Gard Tip and Cap Set

SPLATTER-GARD Tip and Cap Set FOR USE WITH IRRIJET® OR IRRIJET® DS

Registry build 21.09.26
110manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (31), Guangdong (27), Zhejiang (26). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KYZ
Manufacturer City Province Registered as Device types
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Shun SZE Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 22
Wenzhou Zuoyou Medical Technoloyg Co., Ltd. Wenzhou Zhejiang Contract manufacturer 21
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
Primecare Medical (Suzhou) Co., Ltd. Changshu Jiangsu Contract manufacturer 20
Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Ningbo Albert Novosino Co., Ltd. Yuyao Zhejiang Contract manufacturer 17
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16

Showing 12 of 110. All 110 manufacturers in China registered for Syringe, Irrigating (Non Dental)

Record

Regulatory record for Splatter-Gard Tip and Cap Set
Listed by Coopersurgical, Inc., United States
FDA product code KYZ
Device type Syringe, Irrigating (Non Dental)
Device class Class 1
Regulation 21 CFR 880.6960
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2017-09-15
Record revised 2024-02-28 (version 4)

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
Packaging Pack of 4, pack of 10

Catalogue Numbers

Catalogue numbers for Splatter-Gard Tip and Cap Set
Catalogue number Size Status
55-6100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
FibriJet Micromedics, Inc. 35
LSL Healthcare Lsl Industries, Inc. 24
Medline Medline Industries, Inc. 21
Baria Shenzhen Baria Technology Co., Ltd. 20
Monoject Cardinal Health 200, LLC 17
Centurion Centurion Medical Products Corporation 17
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 14
Busse Hospital Disposables Robert Busse & Co., Inc. 12
Ear and Ulcer Syringe C.R. Bard, Inc. 12
Cardinal Health Cardinal Health 200, LLC 12
Nordson Medical Micromedics, Inc. 10
Integra® Miltex® Integra LifeSciences Production Corporation 9

Showing 12 of 129. All products under Syringe, Irrigating (Non Dental)

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