Regard™
Robot GYN Mercy ST Anthony
1manufacturer
26catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Resource Optimization & Innovation, L.L.C. |
|---|---|
| FDA product code | OHD |
| Device type | Gynecological Laparoscopic Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Premarket notification | Exempt |
| Record published | 2017-11-22 |
| Record revised | 2020-08-27 (version 5) |
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 6 |
| Distribution end date | 2020-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GY0958 | Withdrawn | |
| OB0122 | Withdrawn | |
| GY0868 | Withdrawn | |
| GY0435 | Withdrawn | |
| GY0579 | Withdrawn | |
| GY1066 | Withdrawn | |
| GS0366 | Withdrawn | |
| LD0370 | Withdrawn | |
| GY0436 | Withdrawn | |
| GY0560 | Withdrawn | |
| GS1027 | Withdrawn | |
| GY0383 | Withdrawn | |
| GY0939 | Withdrawn | |
| LD0186 | Withdrawn | |
| GS0403 | Withdrawn | |
| GY0486 | Withdrawn | |
| GY0964 | Withdrawn | |
| GS0406 | Withdrawn | |
| GY1067 | Withdrawn | |
| GS0228 | Withdrawn | |
| GY0437 | Withdrawn | |
| GY0511 | Withdrawn | |
| GS1028 | Withdrawn | |
| OB0548 | Withdrawn | |
| GY0919 | Withdrawn | |
| OB0102 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 16,238 |
| Medline Industries, Inc. | Medline Industries, Inc. | 6,429 |
| ACS | American Contract Systems, Inc. | 739 |
| Aligned Medical Solutions | Aligned Medical Solutions | 112 |
| Regard™ | ROi CPS LLC | 71 |
| DeRoyal | Deroyal Industries, Inc. | 42 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 15 |
| BR Surgical, LLC | BR Surgical LLC | 15 |
| Medical Action Industries | Medical Action Industries, Inc. | 13 |
| Medline | Medline Industries, Inc. | 11 |
| Halyard | Avid Medical, Inc. | 7 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 4 |
Showing 12 of 14. All products under Gynecological Laparoscopic Kit
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.