N/A

GUDID 04961333248292

Made in Malaysia

HOYA CORPORATION

Flexible video gastroscope

• Primary Device ID: 04961333248292
• NIH Device Record Key: 60ae8b38-5590-4a95-bd3e-72165a0f9d67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: EG29-i10
• 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	04961333248292 [Direct Marking]
GS1	04961333248315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131902

FDA Product Code

• FDS: Gastroscope and accessories, flexible/rigid

Sterilization

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

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

Ethylene Oxide;High-level Disinfectant

[04961333248292]

High-level Disinfectant

[04961333248292]

High-level Disinfectant

[04961333248292]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-22
• Device Publish Date: 2020-12-14

On-Brand Devices [N/A]

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• 14961333221612: PROfILE Single Use Endoscope Cleaning Brush Kits
• 14961333221438: PENTAX Medical single use suction control valve
• 04961333233007: ED34-i10T2
• 04961333234066: EC34-i10TL
• 04961333233991: EG34-i10
• 04961333222162: EB19-J10U
• 04961333239634: PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U
• 04961333239535: PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR
• 04961333239436: PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT
• 04961333221530: PENTAX Medical Video Bronchoscope EB19-J10
• 04961333221486: PENTAX Medical Video Bronchoscope EB15-J10
• 04961333248292: Made in Malaysia
• 04961333248186: Made in Malaysia
• 04961333248155: Made in Malaysia
• 04961333248124: Made in Malaysia
• 04961333248988: PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT (Made in Malaysia)
• 04961333248902: PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR (Made in Malaysia)
• 04961333248827: PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U (Made in Malaysia)
• 04961333245802: PENTAX Medical Video Bronchoscope EB11-J10
• 04961333245987: PENTAX Medical Video Upper GI Scope EG17-J10
• 04961333251315: PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia, Electronic IFU)
• 04961333251148: PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia, Electronic IFU)
• 04961333221417: PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Electronic IFU)
• 04961333221370: PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Electronic IFU)
• 04961333221325: PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Electronic IFU)
• 04961333246168: PENTAX Medical Video Duodenoscope ED32-i10
• 04961333251575: PENTAX Medical Video Bronchoscope EB11-J10 (Made in Malaysia)
• 04961333251490: PENTAX Medical Video Bronchoscope EB19-J10 (Made in Malaysia)
• 04961333251223: "PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia, Electronic IFU)