PENTAX

GUDID 04961333228409

Perform cleaning, high-level disinfection, and/or sterilization according to the procedure specified in the Instructions for Use (Reprocessing) of thi

HOYA CORPORATION

Flexible ultrasound gastroduodenoscope

• Primary Device ID: 04961333228409
• NIH Device Record Key: 4e469a14-6839-4d40-b362-5abb5ad5bdf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PENTAX
• Version Model Number: EG-3870UTK
• 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	04961333135899 [Direct Marking]
GS1	04961333228409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130247

FDA Product Code

• ODG: Endoscopic ultrasound system, gastroenterology-urology

Sterilization

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

[04961333228409]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-27
• Device Publish Date: 2017-04-07

On-Brand Devices [PENTAX]

• 04961333233809: VNL-1570STK
• 04961333233793: EG-3270UK
• 04961333229611: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228584: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228577: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228522: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228492: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228478: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228430: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228409: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228362: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228324: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228188: EPK-1000
• 04961333228164: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228133: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228102: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333228058: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227846: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227839: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227747: BS-LC1
• 04961333227686: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227655: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227624: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227563: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227532: KA2422S
• 04961333227518: KA2415S
• 04961333227495: KA2411S
• 04961333227471: KA1815S
• 04961333227273: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227259: BS-LL1
• 04961333227198: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227112: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227099: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333227044: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333226993: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333226863: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333226818: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333225903: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333225811: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333225781: EPK-i5010
• 04961333225743: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333225712: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333225651: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333225224: EPK-p(C)
• 04961333225040: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333225026: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333224982: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333224951: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333224920: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci
• 04961333224913: Perform cleaning, high-level disinfection, and/or sterilization according to the procedure speci