FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925039445
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
SPL-W
Device description
SHOCKPULSE LITHOTRIPSY WRENCH
Published
2018-09-14
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
FEOLithotriptor, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEOLithotriptor, UltrasonicGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142428000
K171024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142428000Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc.2014-11-13FEO
K171024000ShockPulse-SE Lithotripsy SystemCybersonics, Inc.2017-08-21FEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925039445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925039445008219250394458219250394450821925039445

GMDN Terms#

Term, Definition table
TermDefinition
Electrohydraulic/pneumatic lithotripsy system probe, urinary, reusableA slender, rod-like device intended to be used as part of an intracorporeal lithotripsy system to transmit shock waves from electrohydraulic or pneumatic sources directly to a calculus in the urinary tract (i.e., kidneys, ureters, and bladder), providing high-speed fragmentation of the calculus in situ. It is typically made of high-grade stainless steel, may be rigid or semi-flexible, and is available in a variety of sizes and lengths. It may be introduced endoscopically through a natural body orifice or a surgically made opening. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925033900DIEGO701390022024-07-25
00821925033917DIEGO701390062024-07-24
00821925034419DIEGO701390332024-07-23
00821925034730Gyrus ACMI703531002017-05-11
00821925034754Gyrus ACMI703531122017-05-11
00821925035935OLYMPUS37402016-10-03
00821925001428GYRUS ACMICW-USLPC2016-10-13
00821925035874OLYMPUS30002016-09-30
00821925035911Gyrus ACMI34002016-10-12
00821925041547Gyrus ACMI30252016-09-30
00821925010567Gyrus ACMI39992024-07-24
00821925002746Gyrus ACMIENDO-ST2016-10-14
00821925011410DIEGO703390012016-10-12
00821925011441DIEGO703380002017-05-11
00821925021594SMART701421682015-10-24
00821925021617VOCOM701430192015-10-24
00821925026179Diego703380122016-10-06
00821925028746Diego703390002016-10-06
00821925034174Gyrus ACMI701410322015-10-24
00821925035898OLYMPUS30062016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2024-09-03
00821925044180SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044210SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044227SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044234SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044241SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043787SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043794SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043800SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043824SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043725SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043732SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043749SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043756SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043763SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043817OlympusGyrus ACMI, LLCFEO2024-07-23
04953170026782Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-18
04953170318818Probe for LUS-2 2.0mm O.D.OLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-17
04953170026799Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-16
00821925043671ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043688ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043695ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043701ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043718ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925044203ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043831ShockPulseGyrus ACMI, LLCFEO2020-03-02
00821925044197ShockPulseGyrus ACMI, LLCFEO2020-03-02
07613353125912LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2019-11-15
07613353156114LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03
07613353156121LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03