FULL-OPTY FLP1709

GUDID 18033959221133

Semiautomatic soft tissue biopsy device 17G; 9 cm

STERYLAB SRL

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 18033959221133
• NIH Device Record Key: 68aea331-7478-4ed6-9ce5-da591a523bd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FULL-OPTY
• Version Model Number: FULL-OPTY
• Catalog Number: FLP1709
• Company DUNS: 439659574
• Company Name: STERYLAB SRL
• 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	08033959221136 [Primary]
GS1	18033959221133 [Package]; Contains: 08033959221136; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051506

FDA Product Code

• FCG: Biopsy Needle

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: 2019-10-11
• Device Publish Date: 2019-10-03

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