CANNULATED PEDIGUARD P2HE1000

GUDID 03662674000068

SPINEGUARD

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

• Primary Device ID: 03662674000068
• NIH Device Record Key: 3579613a-0fcf-4993-b0dc-f3068b53d493
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CANNULATED PEDIGUARD
• Version Model Number: CANNULATED PEDIGUARD HANDLE
• Catalog Number: P2HE1000
• 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

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	03662674000068 [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: 2016-08-29

On-Brand Devices [CANNULATED PEDIGUARD]

• 03662674000167: CANNULATES PEDIGUARD CANNULA 120mm
• 03662674000143: CANNULATED PEDIGUARD STARTER STYLET - TROCAR 120mm
• 03662674000136: CANNULATED PEDIGUARD STARTER STYLET - BEVEL 120mm
• 03662674000112: CANNULATED PEDIGUARD NEEDLE 2
• 03662674000105: CANNULATED PEDIGUARD STARTER STYLET - TROCAR
• 03662674000099: CANNULATED PEDIGUARD STARTER STYLET - BEVEL
• 03662674000082: CANNULATED PEDIGUARD CANNULA 160mm
• 03662674000075: CANNULATED PEDIGUARD NEEDLE 1
• 03662674000068: CANNULATED PEDIGUARD HANDLE