| Primary Device ID | B13095251 |
| NIH Device Record Key | 108c8273-09f4-428e-ad34-bfcbfd1384b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guardian Intraoperative Lead, Medium |
| Version Model Number | 9525 |
| Catalog Number | 9525 |
| Company DUNS | 832575364 |
| Company Name | Checkpoint Surgical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com | |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com | |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com | |
| Phone | 2163789107 |
| regulatory@checkpointsurgical.com |
| Width | 7 Millimeter |
| Width | 7 Millimeter |
| Width | 7 Millimeter |
| Width | 7 Millimeter |
| Width | 7 Millimeter |
| Width | 7 Millimeter |
| Width | 7 Millimeter |
| Width | 7 Millimeter |
| Width | 7 Millimeter |
| Width | 7 Millimeter |
| Width | 7 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B13095250 [Primary] |
| HIBCC | B13095251 [Package] Contains: B13095250 Package: pouch [1 Units] In Commercial Distribution |
| HIBCC | B13095252 [Package] Package: sales carton [1 Units] In Commercial Distribution |
| HIBCC | B13095253 [Package] Contains: B13095252 Package: Shipping box [4 Units] In Commercial Distribution |
| PDQ | Neurosurgical Nerve Locator |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-10 |
| Device Publish Date | 2021-09-02 |
| B130NS3020K23 - Checkpoint Nerve Repair Kit | 2023-09-11 The CHECKPOINT NERVE REPAIR KIT is a convenience kit of two (2) NeuroShield chitosan membranes (30mm x 20mm) and one (1) Checkpo |
| 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 |