Aveta Flex Disposable Resecting Device, 2.9 mm 210-080

GUDID 00850006759330

Aveta Flex Disposable Resecting Device, 2.9 mm, for use with Aveta System

MEDITRINA, INC.

Tissue morcellation system handpiece, line-powered

• Primary Device ID: 00850006759330
• NIH Device Record Key: 4989175c-77af-4feb-9422-3a4f968e2092
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveta Flex Disposable Resecting Device, 2.9 mm
• Version Model Number: 210-080
• Catalog Number: 210-080
• Company DUNS: 080570262
• Company Name: MEDITRINA, INC.
• 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	00850006759316 [Primary]
GS1	00850006759330 [Package]; Contains: 00850006759316; Package: shelf carton [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190372

FDA Product Code

• HIG: Insufflator, Hysteroscopic

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: 2020-12-03
• Device Publish Date: 2020-11-25

Devices Manufactured by MEDITRINA, INC.

• 00850006759811 - Aveta Drape Pump: 2025-04-21 Aveta Drape Pump
• 00850006759705 - Aveta Waste Management Accessory: 2024-10-22 Aveta Waste Management Accessory for use with Aveta System
• 10850006759733 - Aveta Waste Bag with Tissue Catch: 2024-10-22 Aveta Waste Bag with Tissue Catch for use with Aveta System
• 00850006759477 - Aveta Smol Disposable Resecting Device, 2.9 mm: 2024-05-06 Aveta Smol Disposable Resecting Tip, 2.9 mm, for use with Aveta System
• 00850006759491 - Aveta Smol Disposable Resecting Device, 2.9 mm: 2024-05-06 Aveta Flex Disposable Resecting Tip, 2.9 mm, for use with Aveta System
• 00850006759620 - Aveta Smol Disposable Resecting Device, 2.9 mm: 2024-05-06 Aveta Wave+ Disposable Resecting Tip, 3.9 mm, for use with Aveta System
• 10850006759719 - Aveta Flex+ Disposable Resecting Device, 2.9 mm: 2023-12-11 Aveta Flex+ Disposable Resecting Device, 2.9 mm, for use with Aveta System
• 10850006759726 - Aveta Max+ Disposable Resecting Device, 3.9 mm: 2023-12-11 Aveta Max+ Disposable Resecting Device, 3.9 mm, for use with Aveta System