Aligned Medical Solutions
C-Section Pack
3manufacturers in China registered for this device type
3catalogue 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 | Aligned Medical Solutions |
|---|---|
| FDA product code | OHM |
| Device type | Cesarean Section Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Premarket notification | Exempt |
| Record published | 2018-11-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 4, case of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMS2037A | In distribution | |
| AMS4449 | In distribution | |
| AMS4449A | In distribution |
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 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 32 |
| Medline | Medline Industries, Inc. | 7 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 6 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 6 |
| 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.