CAP

GUDID 04953170054389

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic device sterilization/disinfection tubing set
Primary Device ID04953170054389
NIH Device Record Key91f7e9b4-b7fa-4adc-aefa-e922b8263e99
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAP
Version Model NumberMH-365
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count6
DM Exempttrue
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 Datetrue
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
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Device Identifiers

Device Issuing AgencyDevice ID
GS104953170054389 [Primary]
GS184953170054385 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


[04953170054389]

Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-11-08
Device Publish Date2016-09-21

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

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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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