CANNULATED PEDIGUARD P2ND2201

GUDID 03662674000594

SPINEGUARD

Bone access cannula

• Primary Device ID: 03662674000594
• NIH Device Record Key: 99c939ee-31ce-4c04-8432-88da21487bcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CANNULATED PEDIGUARD
• Version Model Number: Needle XS, Trocar, 130mm
• Catalog Number: P2ND2201
• 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: false
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	03662674000594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241895

FDA Product Code

• SCY: Sacroiliac Joint Guidewire Placement Device

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: 2025-09-26
• Device Publish Date: 2025-09-18

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
• 03662674000594: Needle XS, Trocar, 130mm