Aveta Opal Disposable Hysteroscope, 4.6mm 220-2002

GUDID 00850006759576

Aveta Opal Disposable Hysteroscope, 4.6mm for use with Aveta System

MEDITRINA, INC.

Rigid video hysteroscope

• Primary Device ID: 00850006759576
• NIH Device Record Key: ba3c91ae-2446-43f7-b493-eb63384cd370
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveta Opal Disposable Hysteroscope, 4.6mm
• Version Model Number: 220-2002
• Catalog Number: 220-2002
• 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	00850006759569 [Primary]
GS1	00850006759576 [Package]; Contains: 00850006759569; Package: shelf carton [6 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-01
• Device Publish Date: 2021-06-23

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