WATER CONTAINER (O-RING)

GUDID 04953170079221

OLYMPUS MEDICAL SYSTEMS CORP.

Surgical instrument seal/seal maintenance set

• Primary Device ID: 04953170079221
• NIH Device Record Key: 3fed0e8f-a23b-482f-b288-3576a9d3ba41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WATER CONTAINER (O-RING)
• Version Model Number: MAJ-1028
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 5
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170079221 [Primary]
GS1	84953170079227 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954451

FDA Product Code

• FET: Endoscopic video imaging system/component, gastroenterology-urology

Sterilization

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

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170079221]

High-level Disinfectant;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2018-10-22
• Device Publish Date: 2016-09-21

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170452475 - EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE: 2024-10-14
• 04953170464935 - THUNDERBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip: 2024-09-17
• 04953170464980 - THUNDERBEAT 5 mm, 45 cm, Inline Grip: 2024-09-17
• 14953170464994 - SONICBEAT 5 mm, 10 cm, Inline Grip: 2024-09-17
• 14953170465021 - SONICBEAT 5 mm, 35 cm, Pistol Grip: 2024-09-17
• 14953170465045 - SONICBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 14953170409971 - Single Use Aspiration Needle NA-U401SX: 2024-07-11