FDA.reportPublic FDA data

n.a.

Primary DI
04048551079478
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27077A
Device description
Punch Working Element
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
04048551079478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551079478040485510794784048551079478

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope working guideAn endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

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
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
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