FDA.report

n.a.

Primary DI
04048551086209
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27630035
Device description
Spare Damping Unit, 20 pcs
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
false
Single use
false

Related Records

Product Codes

CodeName
FFKLithotriptor, electro-hydraulic

Product Code Classifications

CodeDeviceSpecialtyClass
FFKLithotriptor, Electro-HydraulicGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551086209PrimaryGS10
04048551256909Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551086209040485510862094048551086209
04048551256909040485512569094048551256909

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315731430
Device count
20
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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04048551425756n.a.40410LS40410LS2025-07-10
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04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

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Primary DIBrandCompanyProduct codePublished
06973204210763Electrohydraulic LithotriptorGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
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06973204210794EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210800EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
00821925043596CYBERWANDGyrus Acmi, Inc.FFK2024-07-25
07613353221836LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311568LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311575LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353176686LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
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07613353214203LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
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04260667540097EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
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04260667540134EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
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04260667540172EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
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04260667540219EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
07290016498455LithospecMEDISPEC LTD.FFK2023-06-08
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