RIGID SCOPES

GUDID 04961333240548

RIGID ENDOSCOPE 70 DEG. 6MM

PENTAX OF AMERICA, INC.

Rigid nasopharyngoscope

• Primary Device ID: 04961333240548
• NIH Device Record Key: e3027455-47ab-4b8a-81f5-f483c101f5c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIGID SCOPES
• Version Model Number: 9108
• 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: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter
• Angle: 70 degree
• Outer Diameter: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333240548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921285

FDA Product Code

• EQL: Laryngostroboscope

Sterilization

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

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

[04961333240548]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-26

On-Brand Devices [RIGID SCOPES]

• 04961333240555: RIDID ENDOSCOPE,STERRAD NX CO
• 04961333240548: RIGID ENDOSCOPE 70 DEG. 6MM
• 04961333240531: RIGID ENDOSCOPE 70 DEG. 10MM