Aveta Pearl Disposable Hysteroscope 214-059

GUDID 00850006759064

Aveta Pearl Disposable Hysteroscope for use with Aveta System

MEDITRINA, INC.

Rigid video hysteroscope

• Primary Device ID: 00850006759064
• NIH Device Record Key: 0bfa7c9b-9b30-4bd2-baec-58cd5ba59742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveta Pearl Disposable Hysteroscope
• Version Model Number: 214-059
• Catalog Number: 214-059
• 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	00850006759064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190372

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-11-27

On-Brand Devices [Aveta Pearl Disposable Hysteroscope ]

• 00850006759064: Aveta Pearl Disposable Hysteroscope for use with Aveta System
• 00850006759262: Aveta Pearl Disposable Hysteroscope for use with Aveta System