Aveta Wave+ Disposable Resecting Device, 3.9 mm 210-2005

GUDID 00850006759606

Aveta Wave+ Disposable Resecting Device, 3.9 mm, for use with Aveta System

MEDITRINA, INC.

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• Primary Device ID: 00850006759606
• NIH Device Record Key: adfc77ad-6b2a-43bc-b63c-98dc258747dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveta Wave+ Disposable Resecting Device, 3.9 mm
• Version Model Number: 210-2005
• Catalog Number: 210-2005
• 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	00850006759590 [Primary]
GS1	00850006759606 [Package]; Contains: 00850006759590; 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: 2021-08-09
• Device Publish Date: 2021-07-30

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