GUDID 04048551086322

SCB Upgrade Kit for Calcusplit

Karl Storz GmbH & Co. KG

Endoscopic video image processing unit Endoscopic video image processing unit
Primary Device ID04048551086322
NIH Device Record Key11ebee6a-e614-42ee-9e03-e7b4ad494af4
Commercial Distribution StatusIn Commercial Distribution
Brand Namen.a.
Version Model Number27630077
Company DUNS315731430
Company NameKarl Storz GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104048551086322 [Primary]
GS104048551086322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFKLithotriptor, electro-hydraulic
FFKLithotriptor, electro-hydraulic


Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-19
Device Publish Date2016-09-23

On-Brand Devices [n.a.]

04048551075623Working Element, bipolar
04048551405116Articulated Arm, only
04048551366967Mobile Stand for 28272 HS
04048551322482Clamping Jaw, with ball joint, small
04048551322475Clamping Jaw, with ball joint, large
04048551313114Extension Rod, 50cm
04048551175811BÜCHS Cheek Retractor, 20.5 cm
04048551175637Elevator, width 8 mm, length 20 cm
04048551175569Elevator, width 5 mm, length 20 cm
04048551078150Pick 90°,bay., downwards, 1 mm, 18 cm
04048551078143Pick 90°, bay., upwards, 1 mm, 18 cm
04048551078105Pick 90°, bay., upwards, 0.5 mm, 18.5 cm
04048551100080Elevator, 4mm, 19cm
04048551365328Suction and Irrigation Tube
04048551365304Suction and Irrigation Tube
04048551337691Irrigation-Suction Sheath for 7230 AE
04048551313848Irrigation Tube, 100K
04048551313824Irrigation Tube for Handpiece
04048551313695Irrigation Tube, 100K
04048551313640Irrigation Tube, 60K
04048551310793Suction and Irrigation Tube, 3 mm
04048551310786Suction and Irrigation Tube, 3 mm
04048551310779Suction and Irrigation Tube, 3 mm
04048551288825TWINFlow Suction/Irrig. Tube, 4mm x 13cm
04048551288801TWINFlow Suction/Irrig. Tube, 4mm x 9cm
04048551288795TWINFlow Suction/Irrig. Tube, 2mm x 13cm
04048551288788TWINFlow Suction/Irrig. Tube, 2mm x 9cm
04048551279526Suction and Irrigation Tube, 13cm
04048551279434WULLSTEIN Suction/Irrigation Tube, 13cm
04048551279427Suction and Irrigation Tube, 15cm
04048551267608Tappet, Ø 12 mm
04048551267462Sleeve, Ø 12 mm
04048551267455Sleeve, Ø 11 mm
04048551267448Sleeve, Ø 9 mm
04048551267431Sleeve, Ø 10 mm
04048551267424Sleeve, Ø 8 mm
04048551267417Sleeve, Ø 7 mm
04048551267394Sleeve, Ø 6 mm
04048551267363Sleeve, Ø 5 mm
04048551267332Tappet, Ø 11 mm
04048551267325Tappet, Ø 10 mm
04048551267318Tappet, Ø 9 mm
04048551267301Tappet, Ø 7 mm
04048551267295Tappet, Ø 8 mm
04048551267288Tappet, Ø 6 mm
04048551267271Tappet, Ø 5 mm
04048551258651Suction and Irrigation Tube
04048551258125Irrigation and Suction tube, size 3 mm
04048551194621Knurled ring, diameter 16 mm

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