checkpointsurgical.comCheckpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
Checkpoint Surgical
CHECKPOINT SURGICAL INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012222873 | 3012222873 | CHECKPOINT SURGICAL INC. | 1 | N | 2026-01-01 | 6050 Oak Tree Blvd Ste 360 Independence OH US 44131 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B13095240 | Guardian Intraoperative Lead, Small - The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm. | 2163789107 | regulatory@checkpointsurgical.com |
| B13095241 | Guardian Intraoperative Lead, Small - The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm. | 2163789107 | regulatory@checkpointsurgical.com |
| B130NS30200 | Checkpoint NeuroShield Chitosan Membrane - NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries. | 216-378-9107 | regulatory@checkpointsurgical.com |
| B130NS30201 | Checkpoint NeuroShield Chitosan Membrane - NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries. | 216-378-9107 | regulatory@checkpointsurgical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 202936 | 1702655642 | K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | ETN | 2021-08-26 |
| 202936 | 1934876263 | K190246 | NeuroShield | JXI | 2019-05-31 |
| 202936 | 1685173420 | K150005 | Checkpoint, Checkpoint Head & Neck | ETN | 2015-02-19 |
| 202936 | 1758004266 | K092292 | CHECKPOINT | ETN | 2009-10-28 |
| 202936 | 1385249087 | K061365 | CHECKPOINT WITH ACCUSTIM TECHNOLOGY | ETN | 2006-07-12 |
| 202936 | 1283887390 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Checkpoint NeuroShield Chitosan Membrane - NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
2023-03-31
ProVeil Hydrogel Membrane - ProVeil™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. ProVeil™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
2023-03-31
Checkpoint Nerve Repair Kit - The CHECKPOINT NERVE REPAIR KIT is a convenience kit of two (2) NeuroShield chitosan membranes (30mm x 20mm) and one (1) Checkpoint Edge Nerve Cutting Kit.
2023-09-01
Checkpoint Nerve Repair Kit - The CHECKPOINT NERVE REPAIR KIT is a convenience kit of one (1) NeuroShield chitosan membrane (40mm x 30mm) and one (1) Checkpoint Edge Nerve Cutting Kit.
2023-09-01
Checkpoint NeuroShield Chitosan Membrane - NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
2023-03-31
Guardian Intraoperative Lead, Small - The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm.
2023-06-01
Guardian Intraoperative Lead, Small - The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm.
2023-06-01
Checkpoint NeuroShield Chitosan Membrane - NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
2023-03-31
ProVeil Hydrogel Membrane - ProVeil™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. ProVeil™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
2023-03-31
Guardian Probe Extension, 12 cm - Probe Extension, 12 cm for use with Checkpoint Stimulators
2022-12-02
Guardian Probe Extension Ball Tip, 12 cm - Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators
2022-12-02
Guardian Probe Extension, 4 cm - Probe Extension, 4 cm for use with Checkpoint Stimulators`
2022-12-02
Guardian Probe Extension, 12 cm - Probe Extension, 12 cm for use with Checkpoint Stimulators
2022-12-02
Guardian Probe Extension Ball Tip, 12 cm - Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators
2022-12-02
Guardian Probe Extension, 4 cm - Probe Extension, 4 cm for use with Checkpoint Stimulators`
2022-12-02
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 removal of exposed nerve. The kit includes three circumferential nerve constraining forceps, two blades, and a silicone visibility background.
2022-05-09
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 removal of exposed nerve. The kit includes three circumferential nerve constraining forceps, two blades, and a silicone visibility background.
2022-05-09
Checkpoint Gemini - Handheld Single-use Surgical Bipolar Nerve Stimulator
2022-03-30
Checkpoint Gemini - Handheld Single-use Surgical Bipolar Nerve Stimulator
2022-03-30
Guardian Intraoperative Lead, Medium - The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Medium size has lead body width of approximately 7mm.
2021-09-02
Guardian Intraoperative Lead, Medium - The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Medium size has lead body width of approximately 7mm.
2021-09-02
Checkpoint Guardian - Handheld Single-use Surgical Nerve Stimulator
2020-07-01
Checkpoint - Surgical Nerve Stimulator/Locator
2017-01-13
Checkpoint Head & Neck - Surgical Nerve Stimulator/Locator
2017-04-18
Checkpoint Guardian - Handheld Single-use Surgical Nerve Stimulator
2020-07-01