QuadVantage
QuadVantage 8mm Disposable Blade Set. One blade Kit is used per surgery/ case and then disposed of. Blades included are intended to be used with the QuadVanatage Cobra Harvester (UDI…
QuadVantage 8mm Disposable Blade Set. One blade Kit is used per surgery/ case and then disposed of. Blades included are intended to be used with the QuadVanatage Cobra Harvester (UDI 00850050146063) and the QuadSabre (UDI 00850050146056).
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Bandex Industrial Corp. | Zhuhai | Guangdong | Contract manufacturer | 14 |
| Zhangjiagang Alldex Commodity Co., Ltd. | Zhangjiagang | Jiangsu | Private-label distributor | 5 |
Record
| Listed by | Quadvantage Technology, Inc. |
|---|---|
| FDA product code | HTS |
| Device type | Knife, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2023-06-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41003 | In distribution | |
| 41004 | In distribution | |
| 41005 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| gSource | Gsource, LLC. | 61 |
| Medline | Medline Industries, Inc. | 21 |
| Best | Lacey Manufacturing Company LLC | 18 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 15 |
| Knife, Orthopedic | Sterilmed, Inc. | 12 |
| Arthroscopic Meniscotome | Sontec Instruments, Inc. | 10 |
| Ambler Surgical | Ambler Surgical, LLC | 8 |
| Kmedic | Teleflex Medical LLC | 7 |
| Nasal/Tendon Knife | Sontec Instruments, Inc. | 6 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 6 |
| Infinity™ | ConMed Corporation | 6 |
| Millennium | Avalign Technologies, Inc. | 5 |
Showing 12 of 87. All products under Knife, Orthopedic
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.