FDA.reportPublic FDA data

Printer Paper Roll

Primary DI
04953170331633
Brand
Printer Paper Roll
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-2003
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEBACCESSORIES, CLEANING, FOR ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120357000ENDOSCOPE REPROCESSOR OER-MINIOlympus Medical Systems Corp.2012-12-20FEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170331633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170331633049531703316334953170331633

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope washer/disinfectorA mains electricity (AC-powered) unit intended to be used for the washing and/or disinfecting of endoscopes with water or an appropriate disinfectant solution. It has built-in features to circulate a solution through the lumen (flushing) of the endoscope; some types may also have built-in drying features.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170437984HALOGEN LAMPMAJ-525N61756012023-04-22
04953170465277AUXILIARY WATER TUBEMAJ-855N34993402025-12-05
04953170452932TRACHEAL INTUBATION FIBERSCOPEOLYMPUS LF-PN44475402022-12-23
04953170437571CONNECTING TUBEMAJ-1503N26450012023-04-22
04953170437588CONNECTING TUBEMAJ-1504N26451012023-04-22
04953170437595CONNECTING TUBEMAJ-1505N26452012023-04-22
04953170437601CONNECTING TUBEMAJ-1508N26453012023-04-22
04953170437625CONNECTING TUBEMAJ-1511N26455012023-04-22
04953170437632CONNECTING TUBEMAJ-1512N26456012023-04-22
04953170437649CONNECTING TUBEMAJ-1513N26457012023-04-22
04953170437656CONNECTING TUBEMAJ-1514N26458012023-04-22
04953170437663CONNECTING TUBEMAJ-1515N26459012023-04-22
04953170437670CONNECTING TUBEMAJ-1516N26460012023-04-22
04953170437687CONNECTING TUBEMAJ-1517N26461012023-04-22
04953170437694CONNECTING TUBEMAJ-1764N30610012023-04-22
04953170437700WATER RESISTANT CAPMD-252N36269012023-04-22
04953170437748Water-resistant capMH-553N36274012023-04-22
04953170438318RETAINING RACKMAJ-840N61790012023-04-22
04953170438325CONNECTOR HANGERMAJ-865N61791012023-04-22
04953170434662ENDOEYE FLEX DEFLECTABLE VIDEOSCOPEOLYMPUS LTF-S190-10N38281332023-04-20

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Primary DI, Brand, Company table
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40677964054448Medivators HookupMEDIVATORS INC.FEB2025-04-04
40677964054622Medivators HookupMEDIVATORS INC.FEB2025-04-04
00860010835241System 83 RevolveWassenburg Medical, Inc.FEB2025-02-24
04260306710577SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
04260306710584SugiQuestAlpha GmbH & Co. KGFEB2024-12-02
10705037069316EVOTECH™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FEB2024-06-20
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