Luer-Split MAJ-2092

GUDID 04953170451980

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable Endoscopic procedure air/water valve, reusable

• Primary Device ID: 04953170451980
• NIH Device Record Key: 79d1ef96-8628-4526-adc3-6330979dad77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luer-Split MAJ-2092
• Version Model Number: MAJ-2092
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170451980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843084

FDA Product Code

• FBO: Cystourethroscope

Sterilization

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

[04953170451980]

High-level Disinfectant;Ethylene Oxide

[04953170451980]

High-level Disinfectant;Ethylene Oxide

[04953170451980]

High-level Disinfectant;Ethylene Oxide

[04953170451980]

High-level Disinfectant;Ethylene Oxide

[04953170451980]

High-level Disinfectant;Ethylene Oxide

[04953170451980]

High-level Disinfectant;Ethylene Oxide

[04953170451980]

High-level Disinfectant;Ethylene Oxide

[04953170451980]

High-level Disinfectant;Ethylene Oxide

[04953170451980]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-15
• Device Publish Date: 2022-08-05

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170452932 - TRACHEAL INTUBATION FIBERSCOPE: 2024-04-22
• 14953170460064 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460088 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460101 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460132 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460330 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460378 - Single Use Biliary Drainage Stent V: 2024-04-02
• 14953170460613 - Single Use Biliary Drainage Stent V: 2024-04-02