CAPSULE ACTIVATOR

GUDID 04953170214332

OLYMPUS MEDICAL SYSTEMS CORP.

Video capsule endoscopy system capsule
Primary Device ID04953170214332
NIH Device Record Keyf2c738fc-bb33-4699-b3ed-6ec56474f5f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAPSULE ACTIVATOR
Version Model NumberMAJ-1478
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
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
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Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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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
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
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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
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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Phone+1(800)401-1086
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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
GS104953170214332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEZSYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2016-09-21

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

04953170452475 - EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE2024-10-14
04953170464935 - THUNDERBEAT 5 mm, 45 cm, Pistol Grip2024-09-17
04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip2024-09-17
04953170464980 - THUNDERBEAT 5 mm, 45 cm, Inline Grip2024-09-17
14953170464994 - SONICBEAT 5 mm, 10 cm, Inline Grip2024-09-17
14953170465021 - SONICBEAT 5 mm, 35 cm, Pistol Grip2024-09-17
14953170465045 - SONICBEAT 5 mm, 45 cm, Pistol Grip2024-09-17
14953170409971 - Single Use Aspiration Needle NA-U401SX2024-07-11

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