Regard™

Kit PVP Prep Solution 1oz

Registry build 21.09.26
24manufacturers in China registered for this device type
147catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (11), Anhui (6), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRO
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Sino Protection (Hefei) Medical Products Co., Ltd. Hefei Anhui Contract manufacturer 18
Changzhou Holymed Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Donghai Xingchen NON-Woven Products Co., Ltd. North Donghai Development Zone, Lianyungang Jiangsu Contract manufacturer 7
Fengyang Jiehong Nonwoven Product Co., Ltd. Chuzhou Anhui Contract manufacturer 7
3A Medical Products Co., Ltd. Liu An Anhui Contract manufacturer 6
Cobes Industries (Jinzhai) Co., Ltd. Luan Anhui Contract manufacturer 6
Lianyungang Aiyeh Non-woven Products Co., Ltd. Lianyungang Jiangsu Contract manufacturer 6
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Ningbo Greetmed Medical Instruments Co., Ltd. Ningbo Zhejiang Specification developer 75
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71

Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray

Record

Regulatory record for Regard™
Listed by Resource Optimization & Innovation, L.L.C.
FDA product code LRO
Device type General Surgery Tray
Device class Class 2
Regulation 21 CFR 878.4370
Premarket notification Exempt
Record published 2016-12-21
Record revised 2022-06-17 (version 8)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Supplied as a kit Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date
Packaging Pack of 2, pack of 3, pack of 4, pack of 6, pack of 8, pack of 20
Distribution end date 2022-11-03

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number Size Status
303398 In distribution
PVP1KIT- REG In distribution
361094 In distribution
GS0139 Withdrawn
GS0369 Withdrawn
GS1006 Withdrawn
GS0147 Withdrawn
GS1032 Withdrawn
GS0742 Withdrawn
GS0466 Withdrawn
GS0417 Withdrawn
GS0292 Withdrawn
GS0008 Withdrawn
GS0516 Withdrawn
GS0826 Withdrawn
UR0242 Withdrawn
GS1007 Withdrawn
GS0590 Withdrawn
GS0498 Withdrawn
GS0791 Withdrawn
GS0411 Withdrawn
GS0551 Withdrawn
UR0224 Withdrawn
GS0324 Withdrawn
GS0915 Withdrawn
GS0817 Withdrawn
GS0996 Withdrawn
GS0794 Withdrawn
GS0691 Withdrawn
GS1050 Withdrawn
GS0912 Withdrawn
GS0217 Withdrawn
GS0940 Withdrawn
GS0531 Withdrawn
UR0024 Withdrawn
GS0823 Withdrawn
GS0757 Withdrawn
GS0582 Withdrawn
GS0598 Withdrawn
GS0336 Withdrawn
GS0606 Withdrawn
UR0205 Withdrawn
GY0421 Withdrawn
GS1019 Withdrawn
OR0388 Withdrawn
GS0986 Withdrawn
GS0195 Withdrawn
GS0999 Withdrawn
HT0151 Withdrawn
GS0221 Withdrawn
GS0373 Withdrawn
GS0853 Withdrawn
GS0917 Withdrawn
GS0918 Withdrawn
GS0243 Withdrawn
GS0995 Withdrawn
GS0204 Withdrawn
GS0777 Withdrawn
GS0302 Withdrawn
GS0359 Withdrawn
GS1065 Withdrawn
GS0131 Withdrawn
GS0735 Withdrawn
GS1000 Withdrawn
GS0181 Withdrawn
GS0767 Withdrawn
GS0660 Withdrawn
GS0086 Withdrawn
GS0838 Withdrawn
GS0251 Withdrawn
GS0772 Withdrawn
GS0621 Withdrawn
GS0396 Withdrawn
GS0669 Withdrawn
GS0301 Withdrawn
GS0782 Withdrawn
GY1020 Withdrawn
GS1052 Withdrawn
GS0731 Withdrawn
GS0797 Withdrawn
GS0815 Withdrawn
GS0222 Withdrawn
GS1036 Withdrawn
GS0257 Withdrawn
GS0802 Withdrawn
UR0279 Withdrawn
GS1043 Withdrawn
GS1021 Withdrawn
GS0740 Withdrawn
GS0136 Withdrawn
GS0135 Withdrawn
OB0043 Withdrawn
GS0349 Withdrawn
GS0706 Withdrawn
GS0816 Withdrawn
GY1022 Withdrawn
GS0752 Withdrawn
GS0724 Withdrawn
GS0934 Withdrawn
ET0196 Withdrawn
SP1053 Withdrawn
GS0129 Withdrawn
GS0681 Withdrawn
GS0503 Withdrawn
GS0445 Withdrawn
GS0676 Withdrawn
GS0510 Withdrawn
GS0984 Withdrawn
GS0191 Withdrawn
GS0766 Withdrawn
GS0085 Withdrawn
GS0003 Withdrawn
GS1045 Withdrawn
GS0773 Withdrawn
GS0218 Withdrawn
GS0807 Withdrawn
GS0293 Withdrawn
GS0650 Withdrawn
UR0050 Withdrawn
GS0392 Withdrawn
GS0197 Withdrawn
ET0225 Withdrawn
GS0169 Withdrawn
GS0904 Withdrawn
GS0441 Withdrawn
GS0325 Withdrawn
GS0930 Withdrawn
GS0461 Withdrawn
GS0304 Withdrawn
GS0643 Withdrawn
GS0750 Withdrawn
UR0098 Withdrawn
GS1085 Withdrawn
GY0704 Withdrawn
GS0179 Withdrawn
GS0573 Withdrawn
GS0155 Withdrawn
GS0810 Withdrawn
GS0947 Withdrawn
GS0014 Withdrawn
GU0410 Withdrawn
SP1051 Withdrawn
UR0187 Withdrawn
PL0211 Withdrawn
GS0780 Withdrawn
GS0121 Withdrawn
GS0420 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 67,931
Medline Industries, Inc. Medline Industries, Inc. 54,362
Avid TruCustom Avid Medical, Inc. 13,498
Halyard Avid Medical, Inc. 12,802
ACS American Contract Systems, Inc. 10,337
SurgiTrack Owens & Minor Distribution, Inc. 5,575
Aligned Medical Solutions Aligned Medical Solutions 3,490
SurgiTrackSM Owens & Minor Distribution, Inc. 3,364
DeRoyal Deroyal Industries, Inc. 2,770
Medline Medline Industries, Inc. 1,960
Henry Schein Henry Schein, Inc. 729
Stradis Stradis Healthcare 685

Showing 12 of 113. All products under General Surgery Tray

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