FDA.reportPublic FDA data

DISPOSABLE MECHANICAL LITHOTRIPTOR

Primary DI
04953170033070
Brand
DISPOSABLE MECHANICAL LITHOTRIPTOR
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
BML-201Q
Device description
DISPOSABLE MECHANICAL LITHOTRIPTOR
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LQCLithotriptor, biliary mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQCLithotriptor, Biliary MechanicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170033077PackageGS11Not in Commercial Distribution
04953170033070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317003307714953170033077
04953170033070049531700330704953170033070

GMDN Terms#

Term, Definition table
TermDefinition
Manual biliary stone fragmenterA manual instrument designed to be inserted through the working channel of an endoscope to trap and fragment/crush biliary stones in situ for the treatment of conditions such as cholelithiasis. It typically consists of a flexible sheath with a braided self-expanding grasping mechanism at the distal end, which has the ability to contract around and fragment stones; it may incorporate a handle and/or be attached to an independent handle. The device is typically used in association with procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic cholecystectomy. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170468308Single Use BML Handle VOLYMPUS MEDICAL SYSTEMS CORP.LQC2026-10-19
00810143890921Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.LQC2024-04-15
04953170462597Single Use Mechanical Lithotriptor VOLYMPUS MEDICAL SYSTEMS CORP.LQC2024-03-25
04953170462610Single Use Mechanical Lithotriptor VOLYMPUS MEDICAL SYSTEMS CORP.LQC2024-03-25
14953170462594Single Use Mechanical Lithotriptor VOLYMPUS MEDICAL SYSTEMS CORP.LQC2024-03-25
14953170462617Single Use Mechanical Lithotriptor VOLYMPUS MEDICAL SYSTEMS CORP.LQC2024-03-25
04953170433658Single Use BML Handle VOLYMPUS MEDICAL SYSTEMS CORP.LQC2022-09-16
14953170433655Single Use BML Handle VOLYMPUS MEDICAL SYSTEMS CORP.LQC2022-09-16
00850033250664Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.LQC2022-08-12
00850033250671Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.LQC2022-08-12
04953170420290Single Use Mechanical Lithotriptor BML-610AOLYMPUS MEDICAL SYSTEMS CORP.LQC2021-12-17
14953170420297Single Use Mechanical Lithotriptor BML-610AOLYMPUS MEDICAL SYSTEMS CORP.LQC2021-12-17
00827002572836COOKCOOK INCORPORATEDLQC2021-05-05
04953170420283OLYMPUSOLYMPUS MEDICAL SYSTEMS CORP.LQC2019-12-10
14953170420280OLYMPUSOLYMPUS MEDICAL SYSTEMS CORP.LQC2019-12-10
08714729296379Trapezoid RXBOSTON SCIENTIFIC CORPORATIONLQC2016-09-24
08714729296386Trapezoid RXBOSTON SCIENTIFIC CORPORATIONLQC2016-09-24
08714729296393Trapezoid RXBOSTON SCIENTIFIC CORPORATIONLQC2016-09-24
08714729296409Trapezoid RXBOSTON SCIENTIFIC CORPORATIONLQC2016-09-24
00827002216044SoehendraCOOK INCORPORATEDLQC2016-09-24
00827002218604SoehendraCOOK INCORPORATEDLQC2016-09-24
00827002254725Conquest TTCCOOK INCORPORATEDLQC2016-09-24
00827002255180Conquest TTCCOOK INCORPORATEDLQC2016-09-24
04048551079478n.a.Karl Storz GmbH & Co. KGLQC2016-09-23
04953170032745Basket WireOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170032769Basket WireOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170032875Basket WireOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170032981Basket WireOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170218347Single Use Mechanical Lithotriptor VOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21
04953170218361Single Use Mechanical Lithotriptor VOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21