Cardinal Health
Sterile FRA KIT
1manufacturer
1catalogue number
Who Else Makes It
Registered in Hubei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | OKY |
| Device type | Cytology Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-05-30 |
| Record revised | 2018-07-23 (version 3) |
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, manufacturing date |
| Packaging | Case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33-1676A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aero-Med | Aero-MED LLC | 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.