FDA.reportPublic FDA data

Single Use Mechanical Lithotriptor V

Primary DI
14953170462594
Brand
Single Use Mechanical Lithotriptor V
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
BML-V237QR-30
Catalog number
N2302931
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
14953170462594PackageGS11In Commercial Distribution
04953170462597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317046259414953170462594
04953170462597049531704625974953170462597

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8019N62211302025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8022N62213302025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8025N62215302025-12-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
04953170033070DISPOSABLE MECHANICAL LITHOTRIPTOROLYMPUS 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
04953170218385Single Use Mechanical Lithotriptor VOLYMPUS MEDICAL SYSTEMS CORP.LQC2016-09-21