N/A

GUDID 04961333251315

PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia, Electronic IFU)

HOYA CORPORATION

Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope Flexible video laryngoscope

• Primary Device ID: 04961333251315
• NIH Device Record Key: f1df2453-dc6e-4b18-8a82-caed3d091b8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: VNL15-J10
• Company DUNS: 691519705
• Company Name: HOYA CORPORATION
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04961333251315 [Direct Marking]
GS1	04961333251322 [Primary]
GS1	04961333251346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172156

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

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

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

[04961333251315]

High-level Disinfectant;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-10
• Device Publish Date: 2022-02-02

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