FIBER BRONCHOSCOPE

GUDID 04961333232697

FIBEROPTIC BRONCHOSCOPE 1.2C 2.7TP 600L (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible fibreoptic bronchoscope

• Primary Device ID: 04961333232697
• NIH Device Record Key: ef3e3eb7-0d23-43d0-abbe-c48fec162dcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBER BRONCHOSCOPE
• Version Model Number: FB-8V
• 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	04961333232697 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951199

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

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

[04961333232697]

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 BRONCHOSCOPE]

• 04961333240258: FIBEROPTICBRONCHOSCOPE 2.6C 5.9TP RO PLS (USED)
• 04961333240241: FIBEROPTICBRONCHOSCOPE 2.0C 4.8TP RO PLS (USED)
• 04961333232697: FIBEROPTIC BRONCHOSCOPE 1.2C 2.7TP 600L (REFURBISHED)
• 04961333232680: FIBEROPTIC BRONCHOSCOPE 2.8C 5.9TP 600L (REFURBISHED)
• 04961333232673: FIBER BRONCHOSCOPE TD5.9,CD2.8 (REFURBISHED)
• 04961333232666: FIBEROPTIC BRONCHOSCOPE 2.2C 4.9TP 600L (REFURBISHED)
• 04961333232659: FIBER BRONCHOSCOPE (REFURBISHED)