ULTRASONIC PROBE

GUDID 04953170063206

"6890130 OLA UM-2R-3 ULTRASONIC PROBE 12M"

OLYMPUS MEDICAL SYSTEMS CORP.

Oesophageal ultrasound imaging transducer, reusable

Primary Device ID	04953170063206
NIH Device Record Key	3fc696db-ee41-448b-8245-3c94f72514a2
Commercial Distribution Status	In Commercial Distribution
Brand Name	ULTRASONIC PROBE
Version Model Number	UM-2R
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
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	04953170063206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K001203

FDA Product Code

ITX	Transducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

[04953170063206]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
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"
04953170467301	UM-S20-17S
04953170467295	UM-S20-20R

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