SINUSCOPE

GUDID 04961333230518

Sinuscope 2.7mm, 0 Wide Angle

PENTAX OF AMERICA, INC.

Rigid nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope Rigid optical nasopharyngoscope

• Primary Device ID: 04961333230518
• NIH Device Record Key: 111d7c3f-e2b0-4402-8e3c-f99168a9906d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINUSCOPE
• Version Model Number: 8850-WA
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, 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: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 0 degree
• Outer Diameter: 2.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333230518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944656

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: 2017-04-06

On-Brand Devices [SINUSCOPE]

• 04961333231652: 8853 SINUSCOPE
• 04961333230570: Sinuscope 4.0mm, 70 Wide Angle
• 04961333230563: Sinuscope 4.0mm, 45 Wide Angle
• 04961333230556: Sinuscope 4.0mm, 30 Wide Angle
• 04961333230549: Sinuscope 4.0mm, 0 Wide Angle
• 04961333230525: Sinuscope 2.7mm, 30 Wide Angle
• 04961333230518: Sinuscope 2.7mm, 0 Wide Angle
• 04961333230211: Sinuscope 4.0mm, 70
• 04961333230204: Sinuscope 4.0mm, 45
• 04961333230198: Sinuscope 4.0mm, 30
• 04961333230181: Sinuscope 4.0mm, 0
• 04961333230174: Sinuscope 2.7mm, 70
• 04961333230167: Sinuscope 2.7mm, 30
• 04961333230150: Sinuscope 2.7mm, 0