SPiN Perc Localization Needle 19ga x 105mm, 2cm marking zone INS-5611

GUDID 00815686021146

VERAN MEDICAL TECHNOLOGIES INC.

Soft-tissue biopsy needle, single-use

• Primary Device ID: 00815686021146
• NIH Device Record Key: c38533ba-06fd-4e01-b1e7-d10a016bc155
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPiN Perc Localization Needle 19ga x 105mm, 2cm marking zone
• Version Model Number: INS-5611
• Catalog Number: INS-5611
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815686021146 [Primary]
GS1	10815686021143 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-25

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