Acumed
4mm Polarus® Cap Screw Assembly
1manufacturer
8catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Acumed LLC, United States |
|---|---|
| FDA product code | HBS |
| Device type | Instrument, Clip Forming/Cutting |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4190 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2015-10-24 |
| Record revised | 2024-03-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2020-09-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HR-0001-S | In distribution | |
| HR-0088-S | In distribution | |
| HR-0050-S | In distribution | |
| HR-0028-S | In distribution | |
| HR-0044-S | In distribution | |
| HR-0024-S | In distribution | |
| HR-0054-S | Withdrawn | |
| HR-0058-S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoBridge™ Idsf Diaphysis Tibial Nail | Merete Gmbh | 4 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 3 |
| Expert Tibia Nail | Auxein medical Private limited | 1 |
| Henry Schein | Henry Schein, 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.