Checkpoint Gemini 9092

GUDID B13090921

Handheld Single-use Surgical Bipolar Nerve Stimulator

Checkpoint Surgical, Inc.

Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system

• Primary Device ID: B13090921
• NIH Device Record Key: d83b782d-24f7-4d43-b9d5-528da7a6b1d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Checkpoint Gemini
• Version Model Number: 9092
• Catalog Number: 9092
• 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: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com
• Phone: 216-378-9107
• Email: regulatory@checkpointsurgical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B13090920 [Primary]
HIBCC	B13090921 [Package]; Contains: B13090920; Package: pouch [1 Units]; In Commercial Distribution
HIBCC	B13090922 [Package]; Package: box [1 Units]; In Commercial Distribution
HIBCC	B13090923 [Package]; Contains: B13090922; Package: shipping carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092292

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: 2022-04-07
• Device Publish Date: 2022-03-30

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: 2023-06-09 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