PEDIGUARD CLASSIC P1-AU412

GUDID 03662674000013

SPINEGUARD

Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable

• Primary Device ID: 03662674000013
• NIH Device Record Key: b91f5da1-6d98-4ad5-974c-66db123f5a2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEDIGUARD CLASSIC
• Version Model Number: PEDIGUARD TRI TIP 3.2mm
• Catalog Number: P1-AU412
• Company DUNS: 260589566
• Company Name: SPINEGUARD
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33145184519
• Email: qara@spineguard.com
• Phone: +33145184519
• Email: qara@spineguard.com
• Phone: +33145184519
• Email: qara@spineguard.com
• Phone: +33145184519
• Email: qara@spineguard.com
• Phone: +33145184519
• Email: qara@spineguard.com
• Phone: +33145184519
• Email: qara@spineguard.com

Device Dimensions

• Outer Diameter: 3.2 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.2 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.2 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.2 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.2 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.2 Millimeter
• Length: 45 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662674000013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143159

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: 2022-06-10
• Device Publish Date: 2016-08-22

Devices Manufactured by SPINEGUARD

• 03662674000006 - PEDIGUARD CLASSIC: 2022-06-10
• 03662674000013 - PEDIGUARD CLASSIC: 2022-06-10
• 03662674000013 - PEDIGUARD CLASSIC: 2022-06-10
• 03662674000020 - PEDIGUARD CLASSIC: 2022-06-10
• 03662674000037 - PEDIGUARD CLASSIC: 2022-06-10
• 03662674000044 - PEDIGUARD CURV: 2022-06-10
• 03662674000051 - PEDIGUARD CURV: 2022-06-10
• 03662674000068 - CANNULATED PEDIGUARD: 2022-06-10
• 03662674000075 - CANNULATED PEDIGUARD: 2022-06-10