Regard™
Obese Prone Positioning Bundle
24manufacturers in China registered for this device type
344catalogue numbers in this listing
6recalls on this code
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.
| 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
| Listed by | ROi CPS LLC |
|---|---|
| FDA product code | LRO |
| Device type | General Surgery Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2024-01-12 |
| Record revised | 2022-06-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 3, pack of 2, pack of 4, pack of 6, pack of 20, pack of 5 |
| Distribution end date | 2026-01-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GS00947G | Withdrawn | |
| UR00024S | Withdrawn | |
| GS00169J | Withdrawn | |
| GS00797I | Withdrawn | |
| SP01161 | Withdrawn | |
| GS00794K | Withdrawn | |
| GS01143C | Withdrawn | |
| GS00139F | Withdrawn | |
| UR00279I | Withdrawn | |
| GS00014N | Withdrawn | |
| GS00155K | Withdrawn | |
| GS00147H | Withdrawn | |
| OB00043U | Withdrawn | |
| GS00129J | Withdrawn | |
| UR00224J | Withdrawn | |
| GS01153A | Withdrawn | |
| GS01214C | Withdrawn | |
| HT00151O | Withdrawn | |
| UR00050M | Withdrawn | |
| GS00349N | Withdrawn | |
| SP01160A | Withdrawn | |
| GS01036A | Withdrawn | |
| GS00823E | Withdrawn | |
| GS01036B | Withdrawn | |
| GS00251J | Withdrawn | |
| GS01176 | Withdrawn | |
| GS00204O | Withdrawn | |
| GS00179O | Withdrawn | |
| OB00043R | Withdrawn | |
| ET01149 | Withdrawn | |
| GS00221H | Withdrawn | |
| GS00417J | Withdrawn | |
| GS00324N | Withdrawn | |
| GS00325F | Withdrawn | |
| UR00098T | Withdrawn | |
| GS00191R | Withdrawn | |
| GS00191Q | Withdrawn | |
| GS00917F | Withdrawn | |
| GS01043D | Withdrawn | |
| GS01214A | Withdrawn | |
| ET00196J | Withdrawn | |
| HT00144M | Withdrawn | |
| GS00996B | Withdrawn | |
| GS00810F | Withdrawn | |
| GS00292C | Withdrawn | |
| GS00904D | Withdrawn | |
| GS01050B | Withdrawn | |
| GS00243B | Withdrawn | |
| GS00301F | Withdrawn | |
| GS00782I | Withdrawn | |
| HT00151N | Withdrawn | |
| GS00810I | Withdrawn | |
| GS00810H | Withdrawn | |
| GS00085AE | Withdrawn | |
| GS00197N | Withdrawn | |
| GS01159A | Withdrawn | |
| GS00179L | Withdrawn | |
| GS00302M | Withdrawn | |
| SP01161C | Withdrawn | |
| GS00086U | Withdrawn | |
| GS00293G | Withdrawn | |
| GS00191P | Withdrawn | |
| GS01085 | Withdrawn | |
| GS01108A | Withdrawn | |
| GS00986C | Withdrawn | |
| GS00794M | Withdrawn | |
| GS00302L | Withdrawn | |
| GS00003T | Withdrawn | |
| GS00853E | Withdrawn | |
| GS00304C | Withdrawn | |
| GS00817F | Withdrawn | |
| GS00349M | Withdrawn | |
| GS00904E | Withdrawn | |
| GS00197L | Withdrawn | |
| GS00257K | Withdrawn | |
| GS01153 | Withdrawn | |
| GS01085A | Withdrawn | |
| SP01183A | Withdrawn | |
| UR00187L | Withdrawn | |
| GS00155M | Withdrawn | |
| GS00396H | Withdrawn | |
| GS00293H | Withdrawn | |
| GS00767M | Withdrawn | |
| GS00999A | Withdrawn | |
| GS01328 | Withdrawn | |
| GS00782N | Withdrawn | |
| GS00086T | Withdrawn | |
| GS00930B | Withdrawn | |
| GS00131K | Withdrawn | |
| GS00940B | Withdrawn | |
| GS00984F | Withdrawn | |
| OB00043T | Withdrawn | |
| GS00003S | Withdrawn | |
| GS00791G | Withdrawn | |
| PL01144 | Withdrawn | |
| GS00802L | Withdrawn | |
| GS00392H | Withdrawn | |
| GY01020F | Withdrawn | |
| UR00098R | Withdrawn | |
| GS00222M | Withdrawn | |
| GS00222L | Withdrawn | |
| UR00098S | Withdrawn | |
| GS01108 | Withdrawn | |
| GS00815B | Withdrawn | |
| GS00086S | Withdrawn | |
| UR00242K | Withdrawn | |
| GS01159 | Withdrawn | |
| SP01160 | Withdrawn | |
| ET00225I | Withdrawn | |
| HT01212 | Withdrawn | |
| GS00823D | Withdrawn | |
| GS00369H | Withdrawn | |
| UR00242J | Withdrawn | |
| GS00014Q | Withdrawn | |
| GS00947C | Withdrawn | |
| GS00257J | Withdrawn | |
| GS00918A | Withdrawn | |
| GS00823C | Withdrawn | |
| GS00301E | Withdrawn | |
| GY00421K | Withdrawn | |
| GS00802K | Withdrawn | |
| GS01327 | Withdrawn | |
| GS00810J | Withdrawn | |
| GS00930D | Withdrawn | |
| GS00014P | Withdrawn | |
| SP01183 | Withdrawn | |
| GS00802M | Withdrawn | |
| GS00984D | Withdrawn | |
| GS00181F | Withdrawn | |
| GS00179K | Withdrawn | |
| GS00155L | Withdrawn | |
| GS00302N | Withdrawn | |
| GS00791E | Withdrawn | |
| ET00225J | Withdrawn | |
| GS00996A | Withdrawn | |
| SP01126 | Withdrawn | |
| GS01043F | Withdrawn | |
| GS00930C | Withdrawn | |
| GS01052C | Withdrawn | |
| ET01149A | Withdrawn | |
| GS00767K | Withdrawn | |
| GS00014O | Withdrawn | |
| SP01240 | Withdrawn | |
| GS01000C | Withdrawn | |
| GS00392F | Withdrawn | |
| GS00008L | Withdrawn | |
| GY01020D | Withdrawn | |
| GS00794N | Withdrawn | |
| GS00359H | Withdrawn | |
| PL00211N | Withdrawn | |
| GS00917E | Withdrawn | |
| GS00995B | Withdrawn | |
| GS01032D | Withdrawn | |
| UR00098Q | Withdrawn | |
| GS00293F | Withdrawn | |
| GS00121AA | Withdrawn | |
| GS00251I | Withdrawn | |
| GS00204P | Withdrawn | |
| GS00917D | Withdrawn | |
| SP01053A | Withdrawn | |
| GS01032B | Withdrawn | |
| GS01043C | Withdrawn | |
| SP01053 | Withdrawn | |
| GS00826B | Withdrawn | |
| GS01006B | Withdrawn | |
| GS00169K | Withdrawn | |
| GS01116 | Withdrawn | |
| GS00934C | Withdrawn | |
| GS00086V | Withdrawn | |
| GY01020E | Withdrawn | |
| GS01065D | Withdrawn | |
| GS00136 | Withdrawn | |
| GS01050C | Withdrawn | |
| GS01329 | Withdrawn | |
| GS01050D | Withdrawn | |
| GS01116A | Withdrawn | |
| GS01000B | Withdrawn | |
| PL00211Q | Withdrawn | |
| GS00917C | Withdrawn | |
| GS01065B | Withdrawn | |
| GS01019B | Withdrawn | |
| GS00995A | Withdrawn | |
| GS00324J | Withdrawn | |
| GS01175 | Withdrawn | |
| GS00147G | Withdrawn | |
| GS01115A | Withdrawn | |
| UR00242I | Withdrawn | |
| GY01022B | Withdrawn | |
| SP01161D | Withdrawn | |
| PL00211P | Withdrawn | |
| GS00197M | Withdrawn | |
| GS00918B | Withdrawn | |
| GS00782M | Withdrawn | |
| GS01159D | Withdrawn | |
| UR00187K | Withdrawn | |
| GS01052B | Withdrawn | |
| HT00151P | Withdrawn | |
| GS01134A | Withdrawn | |
| GS01052D | Withdrawn | |
| GS00324I | Withdrawn | |
| GS00767L | Withdrawn | |
| GS00782K | Withdrawn | |
| GS00420H | Withdrawn | |
| GS01006C | Withdrawn | |
| HT00151L | Withdrawn | |
| GS00802N | Withdrawn | |
| GS00411I | Withdrawn | |
| GS00791D | Withdrawn | |
| GU00410M | Withdrawn | |
| GS01019A | Withdrawn | |
| GS00139E | Withdrawn | |
| GS01007D | Withdrawn | |
| GS00772G | Withdrawn | |
| GS00904C | Withdrawn | |
| GS01050A | Withdrawn | |
| GS00441P | Withdrawn | |
| GS00085AB | Withdrawn | |
| GS01143A | Withdrawn | |
| GS00947F | Withdrawn | |
| GS01032C | Withdrawn | |
| SP01183B | Withdrawn | |
| GS00947E | Withdrawn | |
| GS00191S | Withdrawn | |
| GS00947D | Withdrawn | |
| GS00217S | Withdrawn | |
| OB00043S | Withdrawn | |
| GS01007C | Withdrawn | |
| GS00782O | Withdrawn | |
| GS00257H | Withdrawn | |
| GS00826C | Withdrawn | |
| GS00121Z | Withdrawn | |
| GY00421J | Withdrawn | |
| GS00940A | Withdrawn | |
| GS01134 | Withdrawn | |
| GS00373G | Withdrawn | |
| UR00242L | Withdrawn | |
| UR00098U | Withdrawn | |
| GS00947B | Withdrawn | |
| GS00257I | Withdrawn | |
| GS00204Q | Withdrawn | |
| GY01165A | Withdrawn | |
| GS00396G | Withdrawn | |
| GS00179J | Withdrawn | |
| GS00217Q | Withdrawn | |
| GS00802O | Withdrawn | |
| GS00325E | Withdrawn | |
| GS00441Q | Withdrawn | |
| GS00324L | Withdrawn | |
| GS00008M | Withdrawn | |
| GS00466B | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same 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
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ROi CPS LLC | UDI-DI | 2023-12-18 | Class I | Process control | Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist. | 345 units | 2024-10-03 |
| ROi CPS LLC | UDI-DI | 2023-03-22 | Class II | Nonconforming Material/Component | The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component. | 662 kits | |
| ROi CPS LLC | UDI-DI | 2022-10-20 | Class II | Component change control | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 268 kits | 2026-04-01 |
| ROi CPS LLC | UDI-DI | 2022-05-03 | Class II | Other | Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled. | 24 kits | 2022-06-27 |
Recalls
2 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.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-08-10 | Class II | Nonconforming Material/Component | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products. | 1,200 trays | 2023-06-16 |
| 2020-01-03 | Class II | Other | ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation. | 412 packs | 2020-11-20 |
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.