FIBER LARYNGOSCOPE

GUDID 04961333232789

FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible fibreoptic nasopharyngolaryngoscope

• Primary Device ID: 04961333232789
• NIH Device Record Key: d528e892-9d1b-4170-96e1-055033b39c15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBER LARYNGOSCOPE
• Version Model Number: FNL-15RP3
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04961333232789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921707

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

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

[04961333232789]

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: 2017-04-06

On-Brand Devices [FIBER LARYNGOSCOPE]

• 04961333232796: FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
• 04961333232789: FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
• 04961333232772: FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
• 04961333232765: NASO-PHARYNGO-LRNGO PORTABLE (REFURBISHED)
• 04961333232758: FIBER NASO PHARYNGO LARYNGOSCOPE INTUB 3 (REFURBISHED)