Cardinal Health
Sterile Vaginal Prep Pack
1manufacturer
50catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Fox Hunting E-commerce Co., Ltd. | Shenzhen | Guangdong | Exporter | 7 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | OJW |
| Device type | Shave Prep Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-12 |
| Record revised | 2022-06-17 (version 6) |
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 |
| Storage | Storage environment temperature up to 40 °C |
| Packaging | Case of 25, case of 40, case of 30, case of 50, case of 12, case of 34 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17A3912C | In distribution | |
| 17A3912E | In distribution | |
| 11-6951A | In distribution | |
| 11-2463A | In distribution | |
| 11-6951N | In distribution | |
| 09-6199A | In distribution | |
| 11-6951M | In distribution | |
| 17-8365A | In distribution | |
| 34-4272A | In distribution | |
| 09-9079B | In distribution | |
| 07-9566A | In distribution | |
| 11-6951F | In distribution | |
| 11A2612B | In distribution | |
| 11-6951B | In distribution | |
| 11-6951L | In distribution | |
| SMA29PPNS5 | In distribution | |
| 11-1919A | In distribution | |
| 11-6951H | In distribution | |
| SMA29PPNS4 | In distribution | |
| 17A3912A | In distribution | |
| 39-3767A | In distribution | |
| 39-8365B | In distribution | |
| 34-4272B | In distribution | |
| 17-6990 | In distribution | |
| 17-1538C | In distribution | |
| 11A2612C | In distribution | |
| WN1694137A | In distribution | |
| 39-9079A | In distribution | |
| 34-4272C | In distribution | |
| 39-8365A | In distribution | |
| 17-1538B | In distribution | |
| SMA29PPNS2 | In distribution | |
| 11A2612D | In distribution | |
| 12A1433 | In distribution | |
| SMA29PPNSA | In distribution | |
| 11-6951C | In distribution | |
| 11-6951E | In distribution | |
| 17A3912D | In distribution | |
| 11-2612B | In distribution | |
| 11A2612A | In distribution | |
| 09-6199B | In distribution | |
| 11-6951G | In distribution | |
| 17-1538A | In distribution | |
| 39-8365C | In distribution | |
| 11-6951J | In distribution | |
| SMA29PPNS1 | In distribution | |
| 11-6951K | In distribution | |
| 17A3912B | In distribution | |
| SMA29PPNS3 | In distribution | |
| 09-9079A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Holter Prep Kit | VectraCor, 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.