FDA.reportPublic FDA data

ALT-Pro WALL-MOUNT

Primary DI
04953170351785
Brand
ALT-Pro WALL-MOUNT
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-2020
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
PCVEndoscopic leak tester

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCVEndoscopic Leak TesterGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123704000AUTOMATED ENDOSCOPE LEAK TESTEROlympus Medical Systems Corp.2013-02-04PCV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170351785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170351785049531703517854953170351785

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope leak tester, electricalA mains electricity (AC-powered) instrument designed to test a flexible endoscope for leaks from its internal channels. It is connected to the endoscope using tubing with appropriate connectors to irrigate the channels of the endoscope with air and/or water/alcohol. This process is used for early detection of pinhole leaks to minimize the incidence of water leak damage and costly repair, especially for videoendoscopes. It is typically used by a healthcare provider (i.e., clinical technician) involved in the repair, servicing, and maintenance of flexible endoscopes.

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
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170415180AUTOMATED ENDOSCOPE LEAK TESTER OLYMPUS MEDICAL SYSTEMS CORP.PCV2021-12-17
04953170351761List of Compatible EndoscopesOLYMPUS MEDICAL SYSTEMS CORP.PCV2016-09-21
04953170351778ALT-Pro LEAK TEST AIR TUBEOLYMPUS MEDICAL SYSTEMS CORP.PCV2016-09-21
04953170351792ALT-PRO INTERFACE CABLEOLYMPUS MEDICAL SYSTEMS CORP.PCV2016-09-21