Aveta Max Disposable Resecting Device, 3.9 mm 210-084

GUDID 00850006759354

Aveta Max Disposable Resecting Device, 3.9 mm, for use with Aveta System

MEDITRINA, INC.

Tissue morcellation system handpiece, line-powered

• Primary Device ID: 00850006759354
• NIH Device Record Key: 2d79de36-55e6-42f7-808f-a621264ba1a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveta Max Disposable Resecting Device, 3.9 mm
• Version Model Number: 210-084
• Catalog Number: 210-084
• 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	00850006759323 [Primary]
GS1	00850006759354 [Package]; Contains: 00850006759323; 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

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