FAST-CUT B FSC1425B

GUDID 18033959224035

Biopsy needle for automatic gun 14G; 25cm

STERYLAB SRL

End-cut biopsy gun needle

• Primary Device ID: 18033959224035
• NIH Device Record Key: b80feaa4-bca3-420e-859f-adf5792195be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAST-CUT B
• Version Model Number: FAST-CUT B
• Catalog Number: FSC1425B
• 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	08033959224038 [Primary]
GS1	18033959224035 [Package]; Contains: 08033959224038; Package: [25 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-11
• Device Publish Date: 2019-10-02

On-Brand Devices [FAST-CUT B]

• 18033959224547: Biopsy needle for automatic gun 20G; 15cm
• 18033959224448: Biopsy needle for automatic gun 18G; 25cm
• 18033959224400: Biopsy needle for automatic gun 18G; 20cm
• 18033959224356: Biopsy needle for automatic gun 18G; 15cm
• 18033959224257: Biopsy needle for automatic gun 16G; 25cm
• 18033959224219: Biopsy needle for automatic gun 16G; 20cm
• 18033959224165: Biopsy needle for automatic gun 16G; 15cm
• 18033959224035: Biopsy needle for automatic gun 14G; 25cm
• 18033959220686: Biopsy needle for automatic gun 20G; 25cm
• 18033959220679: Biopsy needle for automatic gun 20G; 20cm
• 18033959220259: Biopsy needle for automatic gun 14G; 20cm
• 18033959220242: Biopsy needle for automatic gun 14G; 15cm