| Primary Device ID | B13092501 |
| NIH Device Record Key | b4bf186e-15ce-4236-959a-2d12cefc9f66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Checkpoint Edge Nerve Cutting Kit |
| Version Model Number | 9250 |
| Catalog Number | 9250 |
| Company DUNS | 832575364 |
| Company Name | Checkpoint Surgical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com | |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com | |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com | |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com | |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com | |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com | |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B13092500 [Primary] |
| HIBCC | B13092501 [Package] Contains: B13092500 Package: pouch [1 Units] In Commercial Distribution |
| HIBCC | B13092502 [Package] Package: box [1 Units] In Commercial Distribution |
| HIBCC | B13092503 [Package] Contains: B13092502 Package: shipping carton [1 Units] In Commercial Distribution |
| HAO | Instrument, Surgical, Non-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-17 |
| Device Publish Date | 2022-05-09 |
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| B130NS4030K13 - Checkpoint Nerve Repair Kit | 2023-09-11 The CHECKPOINT NERVE REPAIR KIT is a convenience kit of one (1) NeuroShield chitosan membrane (40mm x 30mm) and one (1) Checkpoi |
| B13095241 - Guardian Intraoperative Lead, Small | 2023-06-09 The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting ner |
| B130NS30201 - Checkpoint NeuroShield Chitosan Membrane | 2023-04-10 NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed |
| B130NS40300 - Checkpoint NeuroShield Chitosan Membrane | 2023-04-10 NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed |
| B130PV40301 - ProVeil Hydrogel Membrane | 2023-04-10 ProVeil™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. ProVeil™ is designed to be a |
| B13095041 - Guardian Probe Extension, 12 cm | 2022-12-12 Probe Extension, 12 cm for use with Checkpoint Stimulators |
| B13095051 - Guardian Probe Extension Ball Tip, 12 cm | 2022-12-12 Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators |