ATA-CUT ATC1620

GUDID 18033959222383

Menghini modified needle for soft tissue biopsy 16G; 9 cm

STERYLAB SRL

Body aspiration needle, single-use

• Primary Device ID: 18033959222383
• NIH Device Record Key: 3d762d05-1f99-49fa-a021-52ad697435d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATA-CUT
• Version Model Number: ATA-CUT
• Catalog Number: ATC1620
• 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	08033959222386 [Primary]
GS1	18033959222383 [Package]; Contains: 08033959222386; Package: [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051506

FDA Product Code

• KNW: Instrument, Biopsy

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: 2019-10-24
• Device Publish Date: 2019-10-16

On-Brand Devices [ATA-CUT]

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• 18033959222291: Menghini modified needle for soft tissue biopsy 16G; 9 cm