Aveta Disposable Resecting Handset 213-060

GUDID 00850006759286

Aveta Disposable Resecting Handset for use with Aveta System

MEDITRINA, INC.

Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit Tissue morcellation system control unit

• Primary Device ID: 00850006759286
• NIH Device Record Key: 8c3be62b-8de0-4311-8604-f60936813ba2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveta Disposable Resecting Handset
• Version Model Number: 213-060
• Catalog Number: 213-060
• 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	00850006759279 [Primary]
GS1	00850006759286 [Package]; Contains: 00850006759279; Package: Shelf 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: 2020-09-18
• Device Publish Date: 2020-09-10

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