MicroTaper™ Safety Introducer Set

GUDID 20860327000237

SUMMIT ACCESS LLC

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20860327000237
• NIH Device Record Key: 3cefe398-f0b5-4aaf-895f-6e35e5e45766
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroTaper™ Safety Introducer Set
• Version Model Number: SA-07-G060
• Company DUNS: 021348782
• Company Name: SUMMIT ACCESS 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10860327000230 [Primary]
GS1	20860327000237 [Package]; Contains: 10860327000230; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151076

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

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: 2019-06-07
• Device Publish Date: 2016-09-09

On-Brand Devices [MicroTaper™ Safety Introducer Set ]

• 20860327000251: SA-15-G060
• 20860327000244: SA-10-G060
• 20860327000237: SA-07-G060
• 20860327000220: SA-04-G060
• 20860327000213: SA-03-G060