ULTRASONIC GASTROVIDEOSCOPE

GUDID 04953170355431

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope Flexible ultrasound gastroduodenoscope

• Primary Device ID: 04953170355431
• NIH Device Record Key: b265c222-60b9-4c19-9396-dbb48995c4d2
• 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	04953170355431 [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

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

[04953170355431]

High-level Disinfectant;Ethylene Oxide

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 [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