ULTRASONIC GASTROVIDEOSCOPE

GUDID 04953170341748

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible ultrasound gastroduodenoscope

• Primary Device ID: 04953170341748
• NIH Device Record Key: dc9fb3ea-0551-4714-aef9-763587e5de3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Version Model Number: OLYMPUS GF TYPE UC140P-AL5
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170341748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011314

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

Ethylene Oxide;High-level Disinfectant

[04953170341748]

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: 2017-10-06

On-Brand Devices [ULTRASONIC GASTROVIDEOSCOPE]

• 04953170356322: GF-UC140P-AL5 CLA EUS scope, 2.8mm chan
• 04953170356261: GF-UE160-AL5 Radial array EUS scope
• 04953170355448: OLYMPUS GF TYPE UC140P-AL5
• 04953170355431: OLYMPUS GF TYPE UC140P-AL5
• 04953170355349: OLYMPUS GF TYPE UE160-AL5
• 04953170341748: OLYMPUS GF TYPE UC140P-AL5
• 04953170310546: OLYMPUS GF TYPE UE160-AL5
• 04953170203107: OLYMPUS GF TYPE UE160-AL5
• 04953170167638: OLYMPUS GF TYPE UC140P-AL5
• 04953170062803: OLYMPUS GF TYPE UC140P-AL5
• 04953170062797: OLYMPUS GF TYPE UCT140-AL5