Regard™
Tonsils AND Adenoids
2manufacturers in China registered for this device type
76catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | ROi CPS LLC |
|---|---|
| FDA product code | OGR |
| Device type | Ear, Nose, And Throat Surgical Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Premarket notification | Exempt |
| Record published | 2023-03-31 |
| Record revised | 2021-05-25 (version 3) |
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 2, pack of 4, pack of 3, pack of 5, pack of 10, pack of 15 |
| Distribution end date | 2026-01-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ET01068B | Withdrawn | |
| ET01030B | Withdrawn | |
| ET00936A | Withdrawn | |
| ET00326J | Withdrawn | |
| ET01057C | Withdrawn | |
| ET01068A | Withdrawn | |
| ET01030C | Withdrawn | |
| ET01139B | Withdrawn | |
| ET00744J | Withdrawn | |
| ET00432G | Withdrawn | |
| GS00300D | Withdrawn | |
| ET01010B | Withdrawn | |
| ET01057D | Withdrawn | |
| ET00743C | Withdrawn | |
| GS00088Q | Withdrawn | |
| ET00433F | Withdrawn | |
| GS00920C | Withdrawn | |
| ET00702E | Withdrawn | |
| ET00460B | Withdrawn | |
| ET00743B | Withdrawn | |
| GS00088T | Withdrawn | |
| ET01010A | Withdrawn | |
| GS00088U | Withdrawn | |
| ET00701F | Withdrawn | |
| ET01057E | Withdrawn | |
| GS00920C | Withdrawn | |
| ET00262G | Withdrawn | |
| ET00701I | Withdrawn | |
| ET00702F | Withdrawn | |
| ET01139 | Withdrawn | |
| ET01057B | Withdrawn | |
| ET00936B | Withdrawn | |
| ET00326I | Withdrawn | |
| GS00920E | Withdrawn | |
| ET00837E | Withdrawn | |
| GS00920D | Withdrawn | |
| ET01139A | Withdrawn | |
| GS00300B | Withdrawn | |
| GS00088R | Withdrawn | |
| ET00326K | Withdrawn | |
| ET00936C | Withdrawn | |
| ET00837F | Withdrawn | |
| ET00743E | Withdrawn | |
| ET01068 | Withdrawn | |
| ET01057A | Withdrawn | |
| GS01012C | Withdrawn | |
| ET01113 | Withdrawn | |
| ET00433E | Withdrawn | |
| ET00744L | Withdrawn | |
| ET00701GH | Withdrawn | |
| ET00262E | Withdrawn | |
| ET00701G | Withdrawn | |
| ET01010C | Withdrawn | |
| GS01136A | Withdrawn | |
| GS01012B | Withdrawn | |
| ET00743D | Withdrawn | |
| ET00837D | Withdrawn | |
| ET00837C | Withdrawn | |
| ET00326L | Withdrawn | |
| GS01012A | Withdrawn | |
| ET00744I | Withdrawn | |
| ET00837A | Withdrawn | |
| ET01113A | Withdrawn | |
| ET00457E | Withdrawn | |
| ET00914C | Withdrawn | |
| ET00837B | Withdrawn | |
| GS00088V | Withdrawn | |
| ET00744K | Withdrawn | |
| ET00744H | Withdrawn | |
| GS00300C | Withdrawn | |
| ET00262F | Withdrawn | |
| GS00088W | Withdrawn | |
| GS00920B | Withdrawn | |
| GS01136B | Withdrawn | |
| GS01136 | Withdrawn | |
| GS00088S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 16,169 |
| Medline Industries, Inc. | Medline Industries, Inc. | 8,277 |
| ACS | American Contract Systems, Inc. | 472 |
| Centurion | Centurion Medical Products Corporation | 124 |
| Aligned Medical Solutions | Aligned Medical Solutions | 75 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 33 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 22 |
| Stradis Healthcare | Stradis Healthcare | 15 |
| Integra® MicroFrance® | Integra LifeSciences Production Corporation | 14 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 14 |
| DeRoyal | Deroyal Industries, Inc. | 11 |
| Invenio | GRI-Alleset, Inc. | 8 |
Showing 12 of 23. All products under Ear, Nose, And Throat Surgical Tray
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ROi CPS LLC | UDI-DI | 2021-11-30 | Class II | Error in labeling | Kits lacks rubber latex warning label. | 195 kits | 2023-08-07 |
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 |
|---|---|---|---|---|---|
| 2022-10-20 | Class II | Component change control | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. | 200 kits | 2026-04-01 |
| 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. | 44 trays | 2023-06-16 |
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.