Stradis
Birthing/delivery kit
1manufacturer
2catalogue 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 | Stradis Healthcare, United States |
|---|---|
| FDA product code | MLS |
| Device type | Labor And Delivery Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Premarket notification | Exempt |
| Record published | 2022-03-14 |
| Record revised | 2022-06-17 (version 2) |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 689-435 | In distribution | |
| 570-2936 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 3,909 |
| Medline Industries, Inc. | Medline Industries, Inc. | 3,405 |
| ACS | American Contract Systems, Inc. | 244 |
| Centurion | Centurion Medical Products Corporation | 159 |
| Regard™ | ROi CPS LLC | 125 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 63 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 29 |
| Aligned Medical Solutions | Aligned Medical Solutions | 16 |
| Medical Action Industries | Medical Action Industries, Inc. | 11 |
| Medline | Medline Industries, Inc. | 6 |
| Halyard | Avid Medical, Inc. | 6 |
| Devon | Cardinal Health | 4 |
Showing 12 of 16. All products under Labor And Delivery 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.