Surgical Room
custom surgical pack
3manufacturers in China registered for this device type
1catalogue number
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 | Stradis Healthcare, United States |
|---|---|
| FDA product code | PWL |
| Device type | Oral Surgery Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Record published | 2018-08-10 |
| Record revised | 2022-06-17 (version 5) |
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, serial number |
| Distribution end date | 2022-03-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41126cbs | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stradis Healthcare | Stradis Healthcare | 215 |
| Stradis | Stradis Healthcare | 147 |
| Invenio | GRI-Alleset, Inc. | 58 |
| Cardinal Health | Cardinal Health 200, LLC | 16 |
| 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 |
| 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.