PENTAX

GUDID 04961333113545

HOYA CORPORATION

Body-orifice ultrasound imaging transducer cover, basic, sterile

• Primary Device ID: 04961333113545
• NIH Device Record Key: bf24ed83-6780-4cc6-aa2a-5120051c2a2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PENTAX
• Version Model Number: OF-A67
• Company DUNS: 691519705
• Company Name: HOYA CORPORATION
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333113545 [Primary]
GS1	84961333113541 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130247

FDA Product Code

• ODG: Endoscopic ultrasound system, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• 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