Aveta Disposable Resecting Handset 213-029

GUDID 00850006759071

Aveta CDisposable Resecting Handset for use with Aveta System

MEDITRINA, INC.

Tissue morcellation system control unit

• Primary Device ID: 00850006759071
• NIH Device Record Key: 2f3241e0-2fe5-4d21-912d-c5a8ea2ca0ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveta Disposable Resecting Handset
• Version Model Number: 213-029
• Catalog Number: 213-029
• 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	00850006759071 [Primary]
GS1	00850006759170 [Package]; Package: Carton [2 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: 2019-12-05
• Device Publish Date: 2019-11-27

On-Brand Devices [Aveta Disposable Resecting Handset]

• 00850006759071: Aveta CDisposable Resecting Handset for use with Aveta System
• 00850006759286: Aveta Disposable Resecting Handset for use with Aveta System