Regard™

55 catalogue numbers from NU0515, listed by Resource Optimization & Innovation, L.L.C., under Neurological Tray. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
55catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OJG
Manufacturer City Province Registered as Device types
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71

Record

Regulatory record for Regard™
Listed by Resource Optimization & Innovation, L.L.C.
FDA product code OJG
Device type Neurological Tray
Device class Class 1
Regulation 21 CFR 882.4525
Premarket notification Exempt
Record published 2018-03-01
Record revised 2020-08-27 (version 4)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
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 16, pack of 4
Distribution end date 2022-11-03

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number Size Status
NU0515 Withdrawn
NU0363 Withdrawn
NU1039 Withdrawn
NU0683 Withdrawn
NU0909 Withdrawn
NU0748 Withdrawn
NU1086 Withdrawn
NU0041 Withdrawn
NU0219 Withdrawn
NU1047 Withdrawn
NU0395 Withdrawn
NU0303 Withdrawn
NU0168 Withdrawn
NU0206 Withdrawn
NU1018 Withdrawn
NU1001 Withdrawn
NU0840 Withdrawn
NU0341 Withdrawn
NU0698 Withdrawn
NU0096 Withdrawn
NU0974 Withdrawn
NU0141 Withdrawn
NU0285 Withdrawn
NU0565 Withdrawn
NU1049 Withdrawn
NU0968 Withdrawn
NU0018 Withdrawn
NU0504 Withdrawn
NU0937 Withdrawn
NU0040 Withdrawn
NU0160 Withdrawn
NU0787 Withdrawn
NU0962 Withdrawn
NU0925 Withdrawn
NU0140 Withdrawn
NU0259 Withdrawn
NU1048 Withdrawn
NU0921 Withdrawn
NU0480 Withdrawn
NU0527 Withdrawn
NU0278 Withdrawn
NU0991 Withdrawn
NU0961 Withdrawn
NU0655 Withdrawn
NU0263 Withdrawn
NU1023 Withdrawn
NU0981 Withdrawn
NU0193 Withdrawn
NU1046 Withdrawn
NU0299 Withdrawn
NU0553 Withdrawn
NU0980 Withdrawn
CV0246 Withdrawn
NU0651 Withdrawn
NU0010 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 25,194
Medline Industries, Inc. Medline Industries, Inc. 3,084
Avid TruCustom Avid Medical, Inc. 969
ACS American Contract Systems, Inc. 938
Halyard Avid Medical, Inc. 718
Regard™ ROi CPS LLC 208
Aligned Medical Solutions Aligned Medical Solutions 53
V. Mueller Steris Corporation 27
Nico BrainPath Approach Nico Corporation 25
V. Mueller Carefusion 2200, Inc. 13
Invenio GRI Medical & Electronic Technology Co., Ltd. 11
Phasor Phasor Health, LLC 8

Showing 12 of 24. All products under Neurological 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