PENTAX

GUDID 04961333073016

PENTAX Adjustable Luer Lock Seal OF-B82

HOYA CORPORATION

Endoscope working-channel seal

• Primary Device ID: 04961333073016
• NIH Device Record Key: 3469c3b2-2d31-4ad9-89fb-244ee50a86a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PENTAX
• Version Model Number: OF-B82
• Company DUNS: 691519705
• Company Name: HOYA CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: 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	04961333073016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953286

FDA Product Code

• FBN: Choledochoscope And Accessories, Flexible/Rigid

Sterilization

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

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

[04961333073016]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-08
• Device Publish Date: 2023-07-31

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