Regard™
Davinci Urology ACC Bundle
4manufacturers in China registered for this device type
122catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Anhui (2), Jiangsu (1), Zhejiang (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 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medical Sterilizing Co., Ltd. | Hefei | Anhui | Contract manufacturer | 8 |
Record
| Listed by | ROi CPS LLC |
|---|---|
| FDA product code | FDE |
| Device type | Laparoscopy Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Premarket notification | Exempt |
| Record published | 2022-10-27 |
| Record revised | 2025-04-11 (version 4) |
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 3, pack of 4, pack of 6, pack of 5 |
| Distribution end date | 2026-01-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UR01217 | Withdrawn | |
| GS00091AB | Withdrawn | |
| GS00037W | Withdrawn | |
| GU01035B | Withdrawn | |
| GS00467L | Withdrawn | |
| GS00924G | Withdrawn | |
| GS00223M | Withdrawn | |
| UR00847D | Withdrawn | |
| UR01150A | Withdrawn | |
| GS00194L | Withdrawn | |
| GS00408P | Withdrawn | |
| OB00128K | Withdrawn | |
| GS00467K | Withdrawn | |
| OB00142V | Withdrawn | |
| GS00408O | Withdrawn | |
| GS00037U | Withdrawn | |
| LD00370H | Withdrawn | |
| GS00408T | Withdrawn | |
| GS00137X | Withdrawn | |
| GS00273G | Withdrawn | |
| GS00405J | Withdrawn | |
| GS00137V | Withdrawn | |
| GS01166A | Withdrawn | |
| GS01075B | Withdrawn | |
| GS00408R | Withdrawn | |
| GS00273I | Withdrawn | |
| OB00142U | Withdrawn | |
| GS01011B | Withdrawn | |
| GS00017T | Withdrawn | |
| GS00687E | Withdrawn | |
| OB00142T | Withdrawn | |
| UR00746I | Withdrawn | |
| UR00739J | Withdrawn | |
| GS00393J | Withdrawn | |
| GS00091AA | Withdrawn | |
| GS01326 | Withdrawn | |
| GS00703F | Withdrawn | |
| GS00153O | Withdrawn | |
| GS00137U | Withdrawn | |
| GS01075 | Withdrawn | |
| GS00322K | Withdrawn | |
| GS00397L | Withdrawn | |
| GS00146L | Withdrawn | |
| GU00801E | Withdrawn | |
| GS00055J | Withdrawn | |
| GS01141A | Withdrawn | |
| GS00751I | Withdrawn | |
| GS01325 | Withdrawn | |
| GS00237H | Withdrawn | |
| OB00128L | Withdrawn | |
| GS01031D | Withdrawn | |
| GS00137Y | Withdrawn | |
| GS00162P | Withdrawn | |
| GS00393I | Withdrawn | |
| GS00162O | Withdrawn | |
| GS01141 | Withdrawn | |
| UR00739I | Withdrawn | |
| GS01031C | Withdrawn | |
| GS01166 | Withdrawn | |
| GS00223L | Withdrawn | |
| UR00746G | Withdrawn | |
| GU00954F | Withdrawn | |
| GS00924F | Withdrawn | |
| UR01150 | Withdrawn | |
| GS00393H | Withdrawn | |
| GS00254J | Withdrawn | |
| GS01011C | Withdrawn | |
| UR01064 | Withdrawn | |
| GS00408S | Withdrawn | |
| LZ00039P | Withdrawn | |
| GS00703E | Withdrawn | |
| GS01141B | Withdrawn | |
| GU00801G | Withdrawn | |
| UR00847B | Withdrawn | |
| GS00017S | Withdrawn | |
| GS00408Q | Withdrawn | |
| GU00700G | Withdrawn | |
| GS00146M | Withdrawn | |
| GS00037S | Withdrawn | |
| GS00137W | Withdrawn | |
| GS00467J | Withdrawn | |
| GS01075A | Withdrawn | |
| GS00367G | Withdrawn | |
| GS00091Z | Withdrawn | |
| GS00405H | Withdrawn | |
| GU01321 | Withdrawn | |
| GS00751H | Withdrawn | |
| UR00746H | Withdrawn | |
| GU00700H | Withdrawn | |
| GS00153P | Withdrawn | |
| GS00397K | Withdrawn | |
| GS01031E | Withdrawn | |
| OR00345E | Withdrawn | |
| GS00408N | Withdrawn | |
| GU00801F | Withdrawn | |
| GS00372E | Withdrawn | |
| GU00954E | Withdrawn | |
| GS00254K | Withdrawn | |
| GS00405L | Withdrawn | |
| GS00017R | Withdrawn | |
| GS00254M | Withdrawn | |
| GS01075E | Withdrawn | |
| GS01075C | Withdrawn | |
| GS01138 | Withdrawn | |
| GS00241K | Withdrawn | |
| GS00223O | Withdrawn | |
| GS00393G | Withdrawn | |
| GS01075D | Withdrawn | |
| GS00194M | Withdrawn | |
| GU01035C | Withdrawn | |
| GS00254L | Withdrawn | |
| GS00037V | Withdrawn | |
| GS00241L | Withdrawn | |
| GS00254I | Withdrawn | |
| GS00194K | Withdrawn | |
| GS00223N | Withdrawn | |
| GS00322J | Withdrawn | |
| GS00687D | Withdrawn | |
| GS00372D | Withdrawn | |
| GS00405K | Withdrawn | |
| OB00142W | Withdrawn | |
| LZ00039Q | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 23,145 |
| Cardinal Health | Cardinal Health 200, LLC | 9,245 |
| ACS | American Contract Systems, Inc. | 988 |
| Aligned Medical Solutions | Aligned Medical Solutions | 156 |
| DeRoyal | Deroyal Industries, Inc. | 141 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 61 |
| Medline | Medline Industries, Inc. | 19 |
| Halyard | Avid Medical, Inc. | 13 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
Showing 12 of 17. All products under Laparoscopy Kit
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 | 2023-03-22 | 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. | 278 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. | 228 kits | 2026-04-01 |
| 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. | 166 kits | 2026-04-01 |
| ROi CPS LLC | UDI-DI | 2022-05-03 | Class II | Nonconforming Material/Component | Potential for the tip of the electrode to detach during use. | 125 units | 2024-05-31 |
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.