Cardinal Health
Clinic Oral Surgery Pack
3manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | PWL |
| Device type | Oral Surgery Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-11 |
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 2, case of 3, case of 4, case, case of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SEN55OSTAA | In distribution | |
| SEN55OSTAE | In distribution | |
| SENHDOSLGA | In distribution | |
| SEN11OSJH5 | In distribution | |
| PEHDOSV28 | In distribution | |
| SEN55OSNMB | In distribution | |
| SEN11OSJH9 | In distribution | |
| SEN11OSJH8 | In distribution | |
| SEN11OSJH7 | In distribution | |
| SEN55OSTAH | In distribution | |
| SEN55OSTAB | In distribution | |
| SEN55OSNMC | In distribution | |
| SEN55OSTAI | In distribution | |
| SEN55OSNMA | In distribution | |
| SEN55OSTAF | In distribution | |
| SEN55OSTAD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stradis Healthcare | Stradis Healthcare | 215 |
| Stradis | Stradis Healthcare | 147 |
| Invenio | GRI-Alleset, Inc. | 58 |
| Henry Schein | Henry Schein, Inc. | 5 |
| Patient Pack NSU V2 | Stradis Healthcare | 1 |
| Stradis Medical, LLC. | Stradis Healthcare | 1 |
| Hiossen Simple Instrument KIT | Osstem Implant Co., Ltd. | 1 |
| Hiossen Basic Instrument KIT | Osstem Implant Co., Ltd. | 1 |
| Surgical Room | Stradis Healthcare | 1 |
| Instrapac | Robinson Healthcare Limited | 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.