Laparoscopy - 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip, SOLA0533ST12

GUDID 03700512911036

Promepla

Surgical irrigation/aspiration tubing set

• Primary Device ID: 03700512911036
• NIH Device Record Key: d6f6c097-1f7e-4579-a8c2-109a38c385df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laparoscopy - 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip,
• Version Model Number: SOLA0533ST12
• Catalog Number: SOLA0533ST12
• Company DUNS: 401020409
• Company Name: Promepla
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +37797984232
• Email: customer@rocamed.eu

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700512901037 [Primary]
GS1	03700512911036 [Package]; Contains: 03700512901037; Package: Box Label [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152278

FDA Product Code

• FHF: System, Evacuator, Fluid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-10-11

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