WATER-RESISTANT CAP

GUDID 04953170137518

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic device sterilization/disinfection tubing set

• Primary Device ID: 04953170137518
• NIH Device Record Key: 29689e2d-03a3-49fc-ad59-64e3f300b654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WATER-RESISTANT CAP
• Version Model Number: MAJ-1057
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: 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: true
• 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
• 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
• 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
• 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	04953170137518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010591

FDA Product Code

• ODG: Endoscopic ultrasound system, gastroenterology-urology

Sterilization

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

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

[04953170137518]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-10-12

On-Brand Devices [WATER-RESISTANT CAP]

• 04953170368455: MAJ-1174
• 04953170365478: MAJ-962
• 04953170305764: MAJ-1899 ScopeGuide Water-resistent Cap
• 04953170154492: MAJ-1214 A/C WTR RES CAP LTF-160/Q180AC
• 04953170153891: MAJ-1195 Water resistant cap for AT8 EUS
• 04953170143670: MAJ-1174
• 04953170137518: MAJ-1057
• 04953170062971: MAJ-896
• 04953170437748: MH-553