SPiN EWC – Biopsy Guide Kit INS-5700

GUDID 00815686021108

VERAN MEDICAL TECHNOLOGIES INC.

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• Primary Device ID: 00815686021108
• NIH Device Record Key: b761ba9a-06ab-47b4-a403-a4cad53f837f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPiN EWC – Biopsy Guide Kit
• Version Model Number: INS-5700
• Catalog Number: INS-5700
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815686021108 [Primary]
GS1	10815686021105 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122106

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

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