SINUSCOPE

GUDID 04961333230549

Sinuscope 4.0mm, 0 Wide Angle

PENTAX OF AMERICA, INC.

Rigid nasopharyngoscope

• Primary Device ID: 04961333230549
• NIH Device Record Key: b88b3c9f-30d5-4466-b200-237f2d76820a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINUSCOPE
• Version Model Number: 8853-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: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter
• Angle: 0 degree
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333230549 [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