LARYNGOSTROBOSCOPE

GUDID 04961333255016

LARYNGEAL STROBE 9500

PENTAX OF AMERICA, INC.

Laryngostroboscope

• Primary Device ID: 04961333255016
• NIH Device Record Key: 674c87e5-fd77-4cd3-905b-e30173dbfed2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LARYNGOSTROBOSCOPE
• Version Model Number: 9500
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	04961333255016 [Primary]

FDA Product Code

• EQL: Laryngostroboscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-05
• Device Publish Date: 2025-04-25

On-Brand Devices [LARYNGOSTROBOSCOPE]

• 04961333255726: 9500FS, Footswitch "Accessory for 9500 "
• 04961333255719: 9500MC, Lapel Microphone "Accessory for 9500"
• 04961333255702: 9500LX, Laryngeal Microphone "Accessory for 9500"
• 04961333255016: LARYNGEAL STROBE 9500