Regard™

191 catalogue numbers from OR0255, listed by Resource Optimization & Innovation, L.L.C., under Orthopedic Tray. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
191catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OJH
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 OJH
Device type Orthopedic Tray
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2018-03-05
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 4, pack of 12, pack of 8
Distribution end date 2020-08-26

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number Size Status
OR0255 Withdrawn
OR1044 Withdrawn
OR0604 Withdrawn
OR0803 Withdrawn
OR0046 Withdrawn
OR0542 Withdrawn
OR0047 Withdrawn
OR0400 Withdrawn
OR0571 Withdrawn
OR0922 Withdrawn
OR0231 Withdrawn
OR0453 Withdrawn
OR0611 Withdrawn
OR0265 Withdrawn
OR0384 Withdrawn
OR0730 Withdrawn
OR0523 Withdrawn
OR0827 Withdrawn
OR0464 Withdrawn
OR0926 Withdrawn
OR0296 Withdrawn
OR1055 Withdrawn
OR0841 Withdrawn
OR1061 Withdrawn
OR0971 Withdrawn
OR0032 Withdrawn
OR0972 Withdrawn
OR0005 Withdrawn
OR0209 Withdrawn
OR0362 Withdrawn
OR0319 Withdrawn
OR0455 Withdrawn
GS1024 Withdrawn
OR0208 Withdrawn
OR0353 Withdrawn
OR1056 Withdrawn
OR0762 Withdrawn
OR0931 Withdrawn
OR0456 Withdrawn
OR0134 Withdrawn
OR0106 Withdrawn
OR0413 Withdrawn
OR1009 Withdrawn
OR0969 Withdrawn
OR0459 Withdrawn
OR1033 Withdrawn
OR0011 Withdrawn
OR0093 Withdrawn
OR0824 Withdrawn
OR0442 Withdrawn
OR0451 Withdrawn
OR0727 Withdrawn
OR0726 Withdrawn
OR0717 Withdrawn
OR0095 Withdrawn
OR0476 Withdrawn
OR1078 Withdrawn
OR0798 Withdrawn
OR1077 Withdrawn
OR0558 Withdrawn
OR0949 Withdrawn
OR0749 Withdrawn
OR0355 Withdrawn
OR0458 Withdrawn
OR0583 Withdrawn
OR0124 Withdrawn
OR0491 Withdrawn
OR0049 Withdrawn
OR0745 Withdrawn
OR0316 Withdrawn
OR0416 Withdrawn
OR0549 Withdrawn
OR0107 Withdrawn
OR0520 Withdrawn
OR0022 Withdrawn
OR0350 Withdrawn
OR0821 Withdrawn
OR0637 Withdrawn
GS0125 Withdrawn
OR0412 Withdrawn
OR0346 Withdrawn
OR0356 Withdrawn
OR0628 Withdrawn
OR0733 Withdrawn
OR0123 Withdrawn
OR0048 Withdrawn
OR0097 Withdrawn
OR1029 Withdrawn
OR0449 Withdrawn
OR0021 Withdrawn
OR0764 Withdrawn
OR0647 Withdrawn
OR0530 Withdrawn
OR0320 Withdrawn
OR0690 Withdrawn
OR0789 Withdrawn
GS0829 Withdrawn
OR0447 Withdrawn
OR0765 Withdrawn
OR0360 Withdrawn
OR0180 Withdrawn
OR0977 Withdrawn
OR0785 Withdrawn
OR0159 Withdrawn
OR0642 Withdrawn
OR0836 Withdrawn
OR0524 Withdrawn
OR0347 Withdrawn
OR0258 Withdrawn
OR0418 Withdrawn
OR0034 Withdrawn
OR0603 Withdrawn
OR0790 Withdrawn
OR0675 Withdrawn
OR0989 Withdrawn
OR0658 Withdrawn
OR0800 Withdrawn
OR0609 Withdrawn
OR0769 Withdrawn
OR0943 Withdrawn
OR0849 Withdrawn
OR0020 Withdrawn
OR1014 Withdrawn
OR0148 Withdrawn
OR0639 Withdrawn
OR1083 Withdrawn
OR0519 Withdrawn
OR0799 Withdrawn
OR0281 Withdrawn
OR0665 Withdrawn
OR0580 Withdrawn
OR0585 Withdrawn
OR0973 Withdrawn
OR0058 Withdrawn
OR0354 Withdrawn
OR0976 Withdrawn
OR0104 Withdrawn
OR0666 Withdrawn
OR0672 Withdrawn
OR0546 Withdrawn
OR0280 Withdrawn
OR0993 Withdrawn
OR0584 Withdrawn
OR0513 Withdrawn
GS0828 Withdrawn
OR0975 Withdrawn
GS0950 Withdrawn
OR1034 Withdrawn
OR0723 Withdrawn
OR0594 Withdrawn
OR0031 Withdrawn
OR0094 Withdrawn
OR0452 Withdrawn
OR0496 Withdrawn
OR0529 Withdrawn
OR0484 Withdrawn
OR0541 Withdrawn
OR0850 Withdrawn
OR0344 Withdrawn
OR0970 Withdrawn
OR0674 Withdrawn
OR0902 Withdrawn
OR0903 Withdrawn
OR0429 Withdrawn
OR0483 Withdrawn
OR1013 Withdrawn
OR0522 Withdrawn
OR0684 Withdrawn
OR0240 Withdrawn
OR0342 Withdrawn
OR0150 Withdrawn
OR0351 Withdrawn
OR0697 Withdrawn
OR0298 Withdrawn
NU0260 Withdrawn
OR0446 Withdrawn
OR0415 Withdrawn
OR0781 Withdrawn
OR0277 Withdrawn
OR0045 Withdrawn
OR0232 Withdrawn
OR0509 Withdrawn
OR0679 Withdrawn
OR0233 Withdrawn
OR0601 Withdrawn
OR0960 Withdrawn
OR0761 Withdrawn
OR0424 Withdrawn
OR0734 Withdrawn
NU0963 Withdrawn
OR0528 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 95,039
Medline Industries, Inc. Medline Industries, Inc. 53,097
Avid TruCustom Avid Medical, Inc. 3,990
ACS American Contract Systems, Inc. 3,812
Halyard Avid Medical, Inc. 1,313
Aligned Medical Solutions Aligned Medical Solutions 1,272
Regard™ ROi CPS LLC 464
Overwatch Spinal Elements, Inc. 223
Lucent L Spinal Elements, Inc. 95
Invenio GRI Medical & Electronic Technology Co., Ltd. 87
Integra® Ascension Orthopedics, Inc. 81
Sapphire Spinal Elements, Inc. 76

Showing 12 of 367. All products under Orthopedic 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