ULTRASONIC PROBE N5386440

GUDID 04953170467301

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible endoscopic ultrasound imaging transducer
Primary Device ID04953170467301
NIH Device Record Keyc4908357-ffa6-4328-8873-3860d9744dbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRASONIC PROBE
Version Model NumberUM-S20-17S
Catalog NumberN5386440
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170467301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170467301]

Ethylene Oxide


[04953170467301]

Ethylene Oxide


[04953170467301]

Ethylene Oxide


[04953170467301]

Ethylene Oxide


[04953170467301]

Ethylene Oxide


[04953170467301]

Ethylene Oxide


[04953170467301]

Ethylene Oxide


[04953170467301]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-26
Device Publish Date2025-09-18

On-Brand Devices [ULTRASONIC PROBE]

04953170368592"UM-S20-20R-3 ULTRASONIC PROBE"
04953170368578UM-G20-29R
04953170368561UM-3R
04953170368554UM-2R
04953170368523RU-12M-R1
04953170368509RU-75M-R1
04953170368462UM-DG20-31R
04953170368448UM-DP20-25R
04953170368431UM-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"
04953170078705OLA ONLY UM-S20-20R-3 SLIM 20 MHZ PROBE
04953170078682OLA ONLY UM-BS20-26R-3 BALLOON S. PROBE
049531700786686967730 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"
04953170467301UM-S20-17S
04953170467295UM-S20-20R

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