FDA.reportPublic FDA data

Trapezoid RX

Primary DI
08714729296393
Brand
Trapezoid RX
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00510880
Device description
Wireguided Retrieval Basket
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
08714729296393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729296393087147292963938714729296393

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729270133Polaris X™M0047000D0M0047000D02016-09-24
08714729270140Polaris X™M0047001D0M0047001D02016-09-24
08714729270164Polaris X™M0047003D0M0047003D02016-09-24
08714729270171Polaris X™M0047004D0M0047004D02016-09-24
08714729270188Polaris X™M0047005D0M0047005D02016-09-24
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24

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
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
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