Aveta Controller 212-080

GUDID 00850006759019

Aveta Controller

MEDITRINA, INC.

Hysteroscopic irrigation/insufflation system

• Primary Device ID: 00850006759019
• NIH Device Record Key: 9130dfa2-20d0-4f0d-8f6e-39f533ee6549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveta Controller
• Version Model Number: 212-080
• Catalog Number: 212-080
• Company DUNS: 080570262
• Company Name: MEDITRINA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00850006759019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190372

FDA Product Code

• HIG: Insufflator, Hysteroscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-04
• Device Publish Date: 2019-11-26

Devices Manufactured by MEDITRINA, INC.

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• 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
• 00850006759224 - Aveta Tissue Catch: 2023-08-24 Aveta Tissue Catch, for use with Aveta System