Checkpoint Edge Nerve Cutting Kit
The CHECKPOINT EDGE™ Nerve Cutting Kit is a single-use, sterile kit intended to provide surgeon aid in transecting nerve tissue for the purpose of nerve graft preparation, nerve repair, or…
The CHECKPOINT EDGE™ Nerve Cutting Kit is a single-use, sterile kit intended to provide surgeon aid in transecting nerve tissue for the purpose of nerve graft preparation, nerve repair, or removal of exposed nerve. The kit includes three circumferential nerve constraining forceps, two blades, and a silicone visibility background.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Hotry Co., Ltd. | Beijing | Beijing | Manufacturer | 9 |
Record
| Listed by | Checkpoint Surgical Inc., United States |
|---|---|
| FDA product code | HAO |
| Device type | Instrument, Surgical, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4535 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -30 to 60 °C |
| Packaging | Pouch, box, shipping carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9250 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 705 |
| Ambler Surgical | Ambler Surgical, LLC | 597 |
| V. Mueller | Steris Corporation | 577 |
| Millennium | Avalign Technologies, Inc. | 383 |
| Avalign | Avalign Technologies, Inc. | 352 |
| Novo Surgical | Novo Surgical, Inc. | 300 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 283 |
| Boss Instruments | Boss Instruments, Ltd. | 263 |
| Pilling | Teleflex Medical LLC | 156 |
| Instrument, Surgical, Non-Powered | Karl Storz GmbH & Co. KG | 130 |
| Instrument, Surgical, Non-Powered | Fehling Instruments GmbH | 126 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 109 |
Showing 12 of 249. All products under Instrument, Surgical, Non-Powered
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.