MAMMOREP LOOP MLE MLE2015

GUDID 18033959221850

Repleaceable device for breast lesions localization 20G; 15 cm

STERYLAB SRL

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 18033959221850
• NIH Device Record Key: add2ab54-04ed-4d09-a584-1e52ea8db3bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAMMOREP LOOP MLE
• Version Model Number: MAMMOREP LOOP MLE
• Catalog Number: MLE2015
• 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	08033959221853 [Primary]
GS1	18033959221850 [Package]; Contains: 08033959221853; Package: [10 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: 2019-10-11
• Device Publish Date: 2019-10-03

On-Brand Devices [MAMMOREP LOOP MLE]

• 18033959221850: Repleaceable device for breast lesions localization 20G; 15 cm
• 18033959221843: Repleaceable device for breast lesions localization 20G; 11 cm
• 18033959221836: Repleaceable device for breast lesions localization 20G; 9 cm
• 18033959221829: Repleaceable device for breast lesions localization 20G; 6 cm