MicroTaper™ NV Non-Vascular Safety Introducer Set

GUDID 10860327000285

SUMMIT ACCESS LLC

Non-vascular catheter introduction set

• Primary Device ID: 10860327000285
• NIH Device Record Key: 2a551d4b-d3e9-4283-8f80-143517d4da7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroTaper™ NV Non-Vascular Safety Introducer Set
• Version Model Number: SA-15-G100-NT
• Company DUNS: 021348782
• Company Name: SUMMIT ACCESS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10860327000285 [Primary]

FDA Product Code

• KGZ: Accessories, 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: 2022-10-13
• Device Publish Date: 2022-10-05

On-Brand Devices [MicroTaper™ NV Non-Vascular Safety Introducer Set ]

• 10860327000292: SA-15-G100-NT-ST
• 10860327000285: SA-15-G100-NT
• 10860327000278: SA-15-G100-NT-MT