ENTity SDXL Nasopharyngoscope

GUDID 00858119004156

ENTity SDXL NasoView Flexible LED Nasopharyngoscope

OPTIM LLC

Flexible fibreoptic nasopharyngoscope

• Primary Device ID: 00858119004156
• NIH Device Record Key: 573fc1f9-fed6-4d00-a3df-e36ecc0e9c9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENTity SDXL Nasopharyngoscope
• Version Model Number: F015049
• 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	00858119004156 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

Devices Manufactured by OPTIM LLC

• 00858119004132 - ENTity XL Nasopharyngoscope: 2020-05-01 ENTity XL NasoView Flexible LED Nasopharyngoscope
• 00858119004019 - ENT 3.6FL30 Nasopharyngoscope: 2020-04-24 ENT 3.6FL30 Flexible Nasopharyngoscope
• 00085119004132 - ENTity XL Nasopharyngoscope: 2020-04-24 ENTity XL NasoView Flexible LED Nasopharyngoscope
• 00858119004101 - Portable Light Source: 2019-02-21 LED Portable Light Source
• 00858119004002 - ENTity Nasopharyngoscope: 2018-07-06 ENTity Nasoview Flexible LED Nasopharyngoscope
• 00858119004026 - ENT 3.6FP30 Nasopharyngoscope: 2018-07-06 ENT 3.6FP30 Flexible Nasopharyngoscope
• 00858119004125 - ENTity SD Nasopharyngoscope: 2018-07-06 ENTity SD NasoView Flexible LED Nasopharyngoscope
• 00858119004149 - ENTity SD 45X Nasopharyngoscope: 2018-07-06 ENTity SD 45X NasoView Flexible LED Nasopharyngoscope