Guide Glide II® Guidewire Introducer Needle

GUDID M661S010212753

1ga x 2.75", A-Bevel, Clear Plastic Hub, Lubricated, Wing

Spectra Medical Devices, LLC

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• Primary Device ID: M661S010212753
• NIH Device Record Key: b7d5ebfe-f6f1-4543-a14a-d62b1ad9bd84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Glide II® Guidewire Introducer Needle
• Version Model Number: S01021-2.753L
• Company DUNS: 118301171
• Company Name: Spectra Medical Devices, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M661S010212753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082580

FDA Product Code

• DYB: Introducer, Catheter

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: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [Guide Glide II® Guidewire Introducer Needle]

• M661S01321275: Guide Glide II® Guidewire Introducer Needle One-Wall Style, Green Plastic Hub, B-Bevel Echogeni
• M661S01318275: Guide Glide II® Guidewire Introducer Needle One-Wall Style, Pink Plastic Hub, B-Bevel Echogenic
• M661S010212753: 1ga x 2.75", A-Bevel, Clear Plastic Hub, Lubricated, Wing