Guardian Intraoperative Lead, Small 9524

GUDID B13095241

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.

Checkpoint Surgical, Inc.

Nerve-locating system

• Primary Device ID: B13095241
• NIH Device Record Key: 3c3d120f-def7-41c0-9b1d-3dc9fdbb677d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian Intraoperative Lead, Small
• Version Model Number: 9524
• Catalog Number: 9524
• 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

Customer Support Contacts

• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com
• Phone: 2163789107
• Email: regulatory@checkpointsurgical.com

Device Dimensions

• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter
• Width: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B13095240 [Primary]
HIBCC	B13095241 [Package]; Contains: B13095240; Package: Pouch [1 Units]; In Commercial Distribution
HIBCC	B13095242 [Package]; Package: Sales Carton [1 Units]; In Commercial Distribution
HIBCC	B13095243 [Package]; Contains: B13095242; Package: Shipping Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212355

FDA Product Code

• ETN: Stimulator, Nerve

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-09
• Device Publish Date: 2023-06-01

Devices Manufactured by Checkpoint Surgical, Inc.

• 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: 2023-06-09The 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.
• 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