Entellus Medical FocESS Sinuscope ES-30

GUDID 00857326005604

Thirty Degree 3mm FocESS Sinuscope, Autoclavable

ENTELLUS MEDICAL, INC.

Rigid sinoscope

• Primary Device ID: 00857326005604
• NIH Device Record Key: 350453ee-63d8-49d9-85b9-c5de40918b9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entellus Medical FocESS Sinuscope
• Version Model Number: ES-30
• Catalog Number: ES-30
• Company DUNS: 017283879
• Company Name: ENTELLUS MEDICAL, 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: 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 Dimensions

• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter
• Angle: 30 degree
• Outer Diameter: 3 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857326005604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981751

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

[00857326005604]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-30

On-Brand Devices [Entellus Medical FocESS Sinuscope]

• 00857326005628: Seventy Degree 3mm FocESS Sinuscope, Autoclavable
• 00857326005611: Forty-Five Degree 3mm FocESS Sinuscope, Autoclavable
• 00857326005604: Thirty Degree 3mm FocESS Sinuscope, Autoclavable
• 00857326005598: Zero Degree 3mm FocESS Sinuscope, Autoclavable