Regard™
32 catalogue numbers from LD0358, listed by Resource Optimization & Innovation, L.L.C., under Cesarean Section Tray. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
32catalogue numbers in this listing
Who Else Makes It
Concentrated in Anhui (2), 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 |
| 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 | OHM |
| Device type | Cesarean Section Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Premarket notification | Exempt |
| Record published | 2016-12-27 |
| Record revised | 2020-08-27 (version 6) |
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 |
| Distribution end date | 2020-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LD0358 | Withdrawn | |
| LD0608 | Withdrawn | |
| LD0678 | Withdrawn | |
| LD0692 | Withdrawn | |
| LD0843 | Withdrawn | |
| LD0911 | Withdrawn | |
| LD0427 | Withdrawn | |
| LD0910 | Withdrawn | |
| LD0312 | Withdrawn | |
| LD0019 | Withdrawn | |
| LD0274 | Withdrawn | |
| LD0620 | Withdrawn | |
| LD0586 | Withdrawn | |
| LD0477 | Withdrawn | |
| LD0543 | Withdrawn | |
| LD0025 | Withdrawn | |
| LD0663 | Withdrawn | |
| LD0499 | Withdrawn | |
| LD1002 | Withdrawn | |
| LD0109 | Withdrawn | |
| LD0090 | Withdrawn | |
| LD0042 | Withdrawn | |
| LD0156 | Withdrawn | |
| LD0554 | Withdrawn | |
| LD0199 | Withdrawn | |
| LD0846 | Withdrawn | |
| LD0028 | Withdrawn | |
| OB0100 | Withdrawn | |
| LD0646 | Withdrawn | |
| LD0754 | Withdrawn | |
| LD0226 | Withdrawn | |
| LD0056 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 7,091 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5,487 |
| ACS | American Contract Systems, Inc. | 533 |
| Regard™ | ROi CPS LLC | 78 |
| DeRoyal | Deroyal Industries, Inc. | 32 |
| Medline | Medline Industries, Inc. | 7 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 6 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 6 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3 |
| Henry Schein | Henry Schein, Inc. | 2 |
| Halyard | Avid Medical, Inc. | 2 |
| Invenio | GRI-Alleset, Inc. | 1 |
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.