FDA.reportPublic FDA data

UreTron Footswitch Single Connector

Primary DI
00854732006218
Brand
UreTron Footswitch Single Connector
Company
Ultratellege USA Co., Ltd.
Model
URT-FS
Device description
UreTron Single Connector Footswitch
Published
2016-09-01
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
FFKLithotriptor, Electro-Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFKLithotriptor, Electro-HydraulicGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160198000UreTron MultiProbe Lithotripter SystemMed-Sonics Corp.2016-02-23FFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854732006218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854732006218008547320062188547320062180854732006218

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118825182
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854732006034UreTron Rigid Sterile Probe 3.1 x 370mm URT-PR-3.1-370S2016-09-01
00854732006041UreTron Rigid Sterile Probe 3.5 x 370 mmURT-PR-3.5-370S2016-09-01
00854732006058UreTron Rigid Sterile Probe 3.5 x 430mmURT-PR-3.5-430S2016-09-01
00854732006065UreTron Rigid Sterile Probe 3.1 x 430 mmURT-PR-3.1-430S2016-09-01
00854732006072UreTron Semi Rigid Sterile Probe 1.9 x 370 mmURT-PS-1.9-370S2016-09-01
00854732006089UreTron Semi Rigid Sterile Probe 1.9 x 570 mmURT-PS-1.9-570S2016-09-01
00854732006096UreTron Semi Rigid Sterile Probe 1.5 x 270 mmURT-PS-1.5-270S2016-09-01
00854732006102UreTron Semi Rigid Sterile Probe 1.5 x 370 mmURT-PS-1.5-370S2016-09-01
00854732006119UreTron Semi Rigid Sterile Probe 1.5 x 480 mmURT-PS-1.5-480S2016-09-01
00854732006126UreTron Semi Rigid Sterile Probe 1.5 x 570 mmURT-PS-1.5-570S2016-09-01
00854732006140UreTron Semi Rigid Sterile Probe 1.3 x 370 mmURT-PS-1.3-370S2016-09-01
00854732006157UreTron Semi Rigid Sterile Probe 1.3 x 570mmURT-PS-1.3-570S2016-09-01
00854732006164UreTron Semi Rigid Sterile Probe 1.0 x 270 mmURT-PS-1.0-270S2016-09-01
00854732006171UreTron Semi Rigid Sterile Probe 1.0 x 480 mmURT-PS-1.0-480S2016-09-01
00854732006188UreTron Semi Rigid Sterile Probe 1.0 x 570 mmURT-PS-1.0-570S2016-09-01
00854732006195UreTron Flexible Sterile Probe 0.8 x 600 mmURT-PF-0.8-600S2016-09-12
00854732006201UreTron Flexible Sterile Probe 0.8 x 1200 mmURT-PF-0.8-1200S2016-09-12
00854732006294UreTron Flexible Sterile ProbeURT-PF-0.8-1370S2016-09-12
00854732006300UreTron Flexible Sterile ProbeURT-PF-0.8-920S2016-09-12
00854732006003UreTron GeneratorURT-G-US2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260667540257EL27-CompactWalz Elektronik GmbHFFK2025-11-12
06973204210763Electrohydraulic LithotriptorGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210787EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210794EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210800EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-09-03
00821925044173CYBERWANDGyrus ACMI, LLCFFK2024-07-25
00821925043596CYBERWANDGyrus Acmi, Inc.FFK2024-07-25
07613353222413LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311582LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
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
07613353312046LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353214159LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
07613353214203LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
04260667540011EL27-CompactWalz Elektronik GmbHFFK2023-10-25
04260667540059EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540097EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540110EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540134EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540158EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540172EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540196EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540219EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
07290016498455LithospecMEDISPEC LTD.FFK2023-06-08
07613353187101SWISS DolorClastE.M.S. Electro Medical Systems S.A.FFK2022-10-28
07613353001940LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17
07613353001964LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17