ANTENNA LEAD COVER

GUDID 04953170214325

OLYMPUS MEDICAL SYSTEMS CORP.

Video capsule endoscopy system antenna
Primary Device ID04953170214325
NIH Device Record Keye245dff6-b99d-430c-9a2e-757f514a2a04
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTENNA LEAD COVER
Version Model NumberMAJ-1470
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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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
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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
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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
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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
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
GS104953170214325 [Primary]
GS184953170214321 [Unit of Use]

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 Date2017-10-06

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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