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
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

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