Checkpoint Surgical, Inc.

Address:6050 Oak Tree Blvd Ste 360,Independence,OH,44131,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Nerve (ETN) (5) Instrument, Surgical, Non-Powered (HAO) (1) Neurosurgical Nerve Locator (PDQ) (1)

Premarket Exempt

No Yes

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Checkpoint Gemini - B13090920 Catalog Number : 9092

Device Description : Handheld Single-use Surgical Bipolar Nerve Stimulator

Device Class :

Duns Number: 832575364

Premarket Exempt : No

Product Code : ETN

Prescription Use : Yes

Device Count : 1

Checkpoint - B13090941 Catalog Number :

Device Description : Surgical Nerve Stimulator/Locator

Device Class :

Duns Number: 832575364

Premarket Exempt : No

Product Code : ETN

Prescription Use : Yes

Device Count : 1

Checkpoint Guardian - B13090950 Catalog Number : 9095

Device Description : Handheld Single-use Surgical Nerve Stimulator

Device Class :

Duns Number: 832575364

Premarket Exempt : No

Product Code : ETN

Prescription Use : Yes

Device Count : 1

Checkpoint Edge Nerve Cutting Kit - B13092500 Catalog Number : 9250

Device Description : The CHECKPOINT EDGE™ Nerve Cutting Kit is a single-use, sterile kit intended to 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.

Device Class :

Duns Number: 832575364

Premarket Exempt : Yes

Product Code : HAO

Prescription Use : Yes

Device Count : 1

Checkpoint Head & Neck - B13093941 Catalog Number :

Device Description : Surgical Nerve Stimulator/Locator

Device Class :

Duns Number: 832575364

Premarket Exempt : No

Product Code : ETN

Prescription Use : Yes

Device Count : 1

Guardian Intraoperative Lead, Medium - B13095250 Catalog Number : 9525

Device Description : The Guardian Intraoperative Lead is a single-use, sterile medical device accesso 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.

Device Class :

Duns Number: 832575364

Premarket Exempt : No

Product Code : PDQ, ETN

Prescription Use : Yes

Device Count : 1

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