Checkpoint

GUDID B13090941

Surgical Nerve Stimulator/Locator

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: B13090941
• NIH Device Record Key: dc7c94d0-e1d6-4f1b-9300-0de25dcaa96e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Checkpoint
• Version Model Number: 9094
• 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: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@checkpointsurgical.com
• Phone: 2163789107
• Email: info@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	B13090941 [Primary]
HIBCC	B13090942 [Package]; Package: [1 Units]; In Commercial Distribution
HIBCC	B13090943 [Package]; Contains: B13090942; Package: 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-13

Devices Manufactured by CHECKPOINT SURGICAL INC

• B13090951 - Checkpoint Guardian: 2020-07-09 Handheld Single-use Surgical Nerve Stimulator
• B13090941 - Checkpoint: 2018-07-06Surgical Nerve Stimulator/Locator
• B13090941 - Checkpoint: 2018-07-06 Surgical Nerve Stimulator/Locator
• B13093941 - Checkpoint Head & Neck: 2018-07-06 Surgical Nerve Stimulator/Locator