ULTRASONIC PROBE

GUDID 04953170062841

"6842430 OLA RU-12M-R1 RIGID ULTRASOUND R"

OLYMPUS MEDICAL SYSTEMS CORP.

Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer Rectal/vaginal ultrasound imaging transducer

• Primary Device ID: 04953170062841
• NIH Device Record Key: 738f616e-d5bf-4145-baa9-16e0ccc61063
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRASONIC PROBE
• Version Model Number: RU-12M-R1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170062841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926514

FDA Product Code

• ODG: Endoscopic ultrasound system, gastroenterology-urology

Sterilization

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

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

[04953170062841]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-08
• Device Publish Date: 2017-10-06

On-Brand Devices [ULTRASONIC PROBE]

• 04953170368592: "UM-S20-20R-3 ULTRASONIC PROBE"
• 04953170368578: UM-G20-29R
• 04953170368561: UM-3R
• 04953170368554: UM-2R
• 04953170368523: RU-12M-R1
• 04953170368509: RU-75M-R1
• 04953170368462: UM-DG20-31R
• 04953170368448: UM-DP20-25R
• 04953170368431: UM-DP12-25R
• 04953170241000: "OLA ONLY UM-S20-17S MIN. US RADIAL PROBE"
• 04953170181733: "N1799930 OLA UM-DG20-31R GUIDE WIRE, DUA"
• 04953170143663: "N1027530 OLA UM-DP20-25R DUAL PLANE RECO"
• 04953170143649: "N1027430 OLA UM-DP12-25R DUAL PLANE RECO"
• 04953170078705: OLA ONLY UM-S20-20R-3 SLIM 20 MHZ PROBE
• 04953170078682: OLA ONLY UM-BS20-26R-3 BALLOON S. PROBE
• 04953170078668: 6967730 OLA UM-G20-29R-3 WIRE GUIDED ULT
• 04953170063213: "6890230 OLA UM-3R-3 ULTRASONIC PROBE 20M"
• 04953170063206: "6890130 OLA UM-2R-3 ULTRASONIC PROBE 12M"
• 04953170062841: "6842430 OLA RU-12M-R1 RIGID ULTRASOUND R"
• 04953170061837: "5786230 OLA RU-75M-R1 RIGID ULTRASOUND R"