0.016" Stylet, 1235mm L INS-5411

GUDID 10815686021198

VERAN MEDICAL TECHNOLOGIES INC.

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• Primary Device ID: 10815686021198
• NIH Device Record Key: 25f2e7c3-df8c-4722-a5c0-a25a5c5b7369
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 0.016" Stylet, 1235mm L
• Version Model Number: INS-5411
• Catalog Number: INS-5411
• Company DUNS: 181714804
• Company Name: VERAN MEDICAL TECHNOLOGIES INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815686021191 [Primary]
GS1	10815686021198 [Package]; Contains: 00815686021191; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170023

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2020-02-07
• Device Publish Date: 2020-01-30

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