Regard™
61 catalogue numbers from GS0775, listed by Resource Optimization & Innovation, L.L.C., under Laparoscopy Kit. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
61catalogue numbers in this listing
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 | Resource Optimization & Innovation, L.L.C. |
|---|---|
| FDA product code | FDE |
| Device type | Laparoscopy Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Premarket notification | Exempt |
| Record published | 2016-12-23 |
| 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, pack of 5 |
| Distribution end date | 2022-11-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GS0775 | Withdrawn | |
| OR0345 | Withdrawn | |
| GS0194 | Withdrawn | |
| GS0703 | Withdrawn | |
| GU0534 | Withdrawn | |
| GS1031 | Withdrawn | |
| GS0241 | Withdrawn | |
| GS0687 | Withdrawn | |
| GU0700 | Withdrawn | |
| GS0467 | Withdrawn | |
| GS0822 | Withdrawn | |
| GS1075 | Withdrawn | |
| GS0137 | Withdrawn | |
| GU0587 | Withdrawn | |
| UR1064 | Withdrawn | |
| GS0146 | Withdrawn | |
| GS0091 | Withdrawn | |
| GS0649 | Withdrawn | |
| GS0372 | Withdrawn | |
| GS0153 | Withdrawn | |
| GS0640 | Withdrawn | |
| GS0408 | Withdrawn | |
| GS0254 | Withdrawn | |
| GS0162 | Withdrawn | |
| GU0954 | Withdrawn | |
| GU0664 | Withdrawn | |
| GS0635 | Withdrawn | |
| GS0470 | Withdrawn | |
| GS0405 | Withdrawn | |
| OB0142 | Withdrawn | |
| GS0322 | Withdrawn | |
| GS0037 | Withdrawn | |
| GU0801 | Withdrawn | |
| GS0751 | Withdrawn | |
| GS0521 | Withdrawn | |
| GS0367 | Withdrawn | |
| LZ0039 | Withdrawn | |
| GS0397 | Withdrawn | |
| GS0501 | Withdrawn | |
| OR0924 | Withdrawn | |
| UR0746 | Withdrawn | |
| GS1011 | Withdrawn | |
| UR0818 | Withdrawn | |
| GS0478 | Withdrawn | |
| GS0223 | Withdrawn | |
| GU0556 | Withdrawn | |
| GS0776 | Withdrawn | |
| GU1035 | Withdrawn | |
| GS0017 | Withdrawn | |
| GS0699 | Withdrawn | |
| UR0739 | Withdrawn | |
| GS0393 | Withdrawn | |
| GS0612 | Withdrawn | |
| UR0847 | Withdrawn | |
| OB0128 | Withdrawn | |
| GS0924 | Withdrawn | |
| GS0694 | Withdrawn | |
| GS0623 | Withdrawn | |
| GS0273 | Withdrawn | |
| OB0667 | Withdrawn | |
| GS0055 | 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™ | ROi CPS LLC | 122 |
| 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
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.