UreTron Flex Hand Piece

Primary DI
00854732006027
Brand
UreTron Flex Hand Piece
Company
Ultratellege USA Co., Ltd.
Model
URT-TF
Device description
UreTron Flex Hand piece for Flex and Semi Flex Probes
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
00854732006027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854732006027008547320060278547320060270854732006027

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic lithotripsy system handpieceA hand-held ultrasonic device that creates a high frequency vibration through a transducer, when electrical energy is applied to its piezo-ceramic elements, which is transmitted to stones (calculi) via a coaxially attached metal probe, fragmenting the stones. The electrical energy is supplied and regulated by an ultrasonic lithotripsy generator. The stone fragments are removed through the lumen of the probe and transducer by a suction system which is facilitated through the ultrasonic lithotripsy system. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118825182
Device count
1
Serial number
true
Sterilization required before use
true

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