Aveta Opal Reusable Cable 220-2011

GUDID 00850006759583

Aveta Opal Reusable Cable for use with Aveta Opal Disposable Hysteroscope, 4.6mm and Aveta System

MEDITRINA, INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00850006759583
• NIH Device Record Key: af5f84e8-235c-4e3b-a1ee-a2adda9f1fc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aveta Opal Reusable Cable
• Version Model Number: 220-2011
• Catalog Number: 220-2011
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00850006759583 [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: false

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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