SINUSCOPES

GUDID 04961333230532

Sinuscope 2.7mm, 70 Wide Angle

PENTAX OF AMERICA, INC.

Rigid nasopharyngoscope

• Primary Device ID: 04961333230532
• NIH Device Record Key: ccfe9915-4d5c-4d74-a784-daf744ec19b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINUSCOPES
• Version Model Number: 8852-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: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter
• Angle: 70 degree
• Outer Diameter: 2.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333230532 [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

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