Single Use BML Handle V N6154330

GUDID 14953170433655

OLYMPUS MEDICAL SYSTEMS CORP.

Manual biliary stone fragmenter handle, noninvasive, single-use
Primary Device ID14953170433655
NIH Device Record Key910a632a-5c16-48d3-b88e-165bde22d288
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use BML Handle V
Version Model NumberMAJ-2502
Catalog NumberN6154330
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170433658 [Primary]
GS114953170433655 [Package]
Contains: 04953170433658
Package: [1 Units]
In Commercial Distribution

FDA Product Code

LQCLithotriptor, Biliary Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-10-06
Device Publish Date2022-09-16

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

14953170433655 - Single Use BML Handle V2025-10-06
14953170433655 - Single Use BML Handle V2025-10-06
04953170467325 - SUCTION VALVE MAJ-14432025-10-03
04953170467332 - AIR/WATER VALVE MAJ-14442025-10-03
04953170467349 - ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL52025-10-03
04953170467356 - EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT1802025-10-03
04953170467295 - ULTRASONIC PROBE2025-09-26
04953170467301 - ULTRASONIC PROBE2025-09-26
14953170458375 - Single Use Aspiration Needle NA-201SX-40212025-08-22

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.