Clearview Scope Cover 28-36000

GUDID 10818501022394

Clearview Scope Cover

INVOTEC INTERNATIONAL, INC.

Endoscope sheath, single-use

• Primary Device ID: 10818501022394
• NIH Device Record Key: f35e4e53-20c6-4665-a36b-cd51bf331cba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearview Scope Cover
• Version Model Number: 28-36000
• Catalog Number: 28-36000
• Company DUNS: 622812592
• Company Name: INVOTEC INTERNATIONAL, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818501022397 [Primary]
GS1	10818501022394 [Package]; Contains: 00818501022397; Package: Box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080740

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

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: 2022-12-14
• Device Publish Date: 2022-12-06

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