FIBER INTUBATION SCOPE

GUDID 04961333240326

FIBEROPTICINTUBATIONSCOPE 1.2C 3.0TP ROP (USED)

PENTAX OF AMERICA, INC.

Flexible fibreoptic intubation laryngoscope

• Primary Device ID: 04961333240326
• NIH Device Record Key: 3e811df1-c37b-4296-a589-a33edf427f69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIBER INTUBATION SCOPE
• Version Model Number: FI-9RBS
• 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: false
• 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	04961333240326 [Primary]

FDA Product Code

• CAL: Laryngoscope, Non-Rigid

Sterilization

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

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

[04961333240326]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-04-12
• Device Publish Date: 2018-03-12

On-Brand Devices [FIBER INTUBATION SCOPE]

• 04961333240326: FIBEROPTICINTUBATIONSCOPE 1.2C 3.0TP ROP (USED)
• 04961333240319: FIBEROPTICINTUBATIONSCOPE 2.4TP RO PLS (USED)
• 04961333240302: FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP (USED)
• 04961333240296: FIBEROPTICINTUBATIONSCOPE 1.8C 4.1TP ROP (USED)
• 04961333240289: FIBEROPTICINTUBATIONSCOPE 1.4C 3.4TP ROP (USED)