EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

GUDID 04953170355479

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible ultrasound gastroduodenoscope

• Primary Device ID: 04953170355479
• NIH Device Record Key: 1fc5e3b3-2a78-4d8b-9027-d8dad94eff0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Version Model Number: OLYMPUS GF TYPE UCT180
• 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: true
• 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	04953170355479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093395

FDA Product Code

• IYN: System, imaging, pulsed doppler, ultrasonic

Sterilization

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

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

[04953170355479]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE]

• 04953170356346: OLYMPUS GF TYPE UCT180
• 04953170356339: GF-UCT180 Curvilinear EUS scope, 3.7 mm
• 04953170355493: OLYMPUS TGF-UC180J
• 04953170355479: OLYMPUS GF TYPE UCT180
• 04953170355462: OLYMPUS GF TYPE UCT180
• 04953170341809: OLYMPUS GF TYPE UCT180
• 04953170341793: OLYMPUS GF TYPE UCT180
• 04953170328480: "N4472740 OLA TGF-UC180J FORWARD VIEWING"
• 04953170287879: OLYMPUS GF TYPE UCT180