Henry Schein
Shoulder Beach Chair Procedure
1manufacturer
16catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | PPF |
| Device type | Urinary Irrigation Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Premarket notification | Exempt |
| Record published | 2023-08-27 |
| Record revised | 2022-06-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5702171 | 12 | In distribution | |
| 5701611 | In distribution | ||
| 5701661 | In distribution | ||
| 5702159 | 8 | In distribution | |
| 5701579 | In distribution | ||
| 5702164 | 12 | In distribution | |
| 5701573 | In distribution | ||
| 5701691 | In distribution | ||
| 5701601 | In distribution | ||
| 5702172 | 8 | In distribution | |
| 5701576 | In distribution | ||
| 5701586 | In distribution | ||
| 5701575 | In distribution | ||
| 5701571 | In distribution | ||
| 5701654 | In distribution | ||
| 5701599 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 18 |
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.