SPRING-CUT SPG1611

GUDID 18033959220389

Semiautomatic guillottine type instrum. for soft tissue biopsy 16G; 11cm

STERYLAB SRL

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 18033959220389
• NIH Device Record Key: 0c12af45-24c1-44b8-aea1-16c9a2dcdd97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPRING-CUT
• Version Model Number: SPRING-CUT
• Catalog Number: SPG1611
• 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	08033959220382 [Primary]
GS1	18033959220389 [Package]; Contains: 08033959220382; Package: [20 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: 2019-10-10
• Device Publish Date: 2019-10-02

On-Brand Devices [SPRING-CUT]

• 18033959220969: Semiautomatic guillottine type instrum. for soft tissue biopsy 20G; 25cm
• 18033959220952: Semiautomatic guillottine type instrum. for soft tissue biopsy 20G; 20cm
• 18033959220945: Semiautomatic guillottine type instrum. for soft tissue biopsy 20G; 15cm
• 18033959220938: Semiautomatic guillottine type instrum. for soft tissue biopsy 20G; 11cm
• 18033959220921: Semiautomatic guillottine type instrum. for soft tissue biopsy 18G; 25cm
• 18033959220914: Semiautomatic guillottine type instrum. for soft tissue biopsy 18G; 20cm
• 18033959220907: Semiautomatic guillottine type instrum. for soft tissue biopsy 16G; 25cm
• 18033959220891: Semiautomatic guillottine type instrum. for soft tissue biopsy 16G; 20cm
• 18033959220884: Semiautomatic guillottine type instrum. for soft tissue biopsy 14G; 25cm
• 18033959220877: Semiautomatic guillottine type instrum. for soft tissue biopsy 14G; 20cm
• 18033959220860: Semiautomatic guillottine type instrum. for soft tissue biopsy 14G; 15cm
• 18033959220853: Semiautomatic guillottine type instrum. for soft tissue biopsy 14G; 11cm
• 18033959220419: Semiautomatic guillottine type instrum. for soft tissue biopsy 18G; 15cm
• 18033959220402: Semiautomatic guillottine type instrum. for soft tissue biopsy 16G; 15cm
• 18033959220396: Semiautomatic guillottine type instrum. for soft tissue biopsy 18G; 11cm
• 18033959220389: Semiautomatic guillottine type instrum. for soft tissue biopsy 16G; 11cm