FDA.report

n.a.

Primary DI
04048551395264
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27085LK-S
Device description
PROBE,STERILE,ULTRASONIC
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FEOLithotriptor, ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
FEOLithotriptor, UltrasonicGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551395264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551395264040485513952644048551395264

GMDN Terms

TermDefinition
Ultrasonic lithotripsy systemAn assembly of devices designed to use ultrasonic (US) shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. This system can have a variety of configurations and will typically employ endoscopic devices together with a dedicated US transducer and probe (e.g., a sonotrode) during its application. The debris may be forcefully removed (e.g., through irrigation/suction) or passed out by natural means at a later date.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04048551012468NA11900RA11900RA2025-03-28
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2024-09-03
00821925043787SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043794SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043800SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043824SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
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, Inc.FEO2024-07-23
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, Inc.FEO2020-03-03
00821925043688ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043695ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043701ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043718ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925044203ShockPulseGyrus Acmi, Inc.FEO2020-03-03
00821925043831ShockPulseGyrus Acmi, Inc.FEO2020-03-02
00821925044197ShockPulseGyrus Acmi, Inc.FEO2020-03-02
07613353125912LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2019-11-15
00821925039445SHOCKPULSE LITHOTRIPSY WRENCHGyrus Acmi, Inc.FEO2018-09-14
07613353156114LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03
07613353156121LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03
07613353157982LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31
07613353162559LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31
07613353162566LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31
07613353162573LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-08-31