INSPIRA

GUDID 04961333251896

PENTAX Medical Video Colonoscope EC38-i20cL

HOYA CORPORATION

Flexible video colonoscope, reusable

• Primary Device ID: 04961333251896
• NIH Device Record Key: 09daf9dd-97df-476f-a1b8-da196fedb970
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSPIRA
• Version Model Number: EC38-i20cL
• 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	04961333251896 [Direct Marking]
GS1	04961333252169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231249

FDA Product Code

• PEA: Endoscope, Accessories, Image Post-Processing For Color Enhancement

Sterilization

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

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

[04961333251896]

High-level Disinfectant;Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-28
• Device Publish Date: 2023-09-20

On-Brand Devices [INSPIRA]

• 04961333247929: PENTAX Medical Video Processor EPK-i8020c
• 04961333251896: PENTAX Medical Video Colonoscope EC38-i20cL
• 04961333251858: PENTAX Medical Video Upper GI Scope EG29-i20c
• 04961333254934: PENTAX Medical Video Processor EPK-i8020c (ORDER CODE: 90963)