ENTity XL Nasopharyngoscope

GUDID 00858119004132

ENTity XL NasoView Flexible LED Nasopharyngoscope

OPTIM LLC

Flexible fibreoptic nasopharyngoscope

• Primary Device ID: 00858119004132
• NIH Device Record Key: 4a9da37a-9778-4194-8ff2-f63f08783cd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENTity XL Nasopharyngoscope
• Version Model Number: F014721
• Company DUNS: 052927001
• Company Name: OPTIM LLC
• 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: false
• 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	00858119004132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080622

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

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: 2020-05-01
• Device Publish Date: 2020-04-23

On-Brand Devices [ENTity XL Nasopharyngoscope]

• 00085119004132: ENTity XL NasoView Flexible LED Nasopharyngoscope
• 00858119004132: ENTity XL NasoView Flexible LED Nasopharyngoscope