FDA.reportPublic FDA data

Extender Cable, Autolith Touch

Primary DI
00817183020455
Brand
Extender Cable, Autolith Touch
Company
NORTHGATE TECHNOLOGIES INC.
Model
M00546750
Device description
Extender cable for use with Autolith Touch Lithotripter, BSC
Published
2017-02-09
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
K130368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130368000AUTOLITH TOUCH; URO TOUCHNorthgate Technologies, Inc.2013-11-15FFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817183020455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817183020455008171830204558171830204550817183020455

GMDN Terms#

Term, Definition table
TermDefinition
Electrohydraulic lithotripsy systemAn assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
627969264
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817183020844Dual CO2 Cylinder Hose7-650-502025-03-31
10817183020841Dual CO2 Cylinder Hose7-650-502025-03-31
00817183020820StimSite AM-VY1 AdapterAM-VY12024-07-10
00817183020813PUREPNEUMO Tubing Set7-650-012024-07-09
10817183020810PUREPNEUMO Tubing Set7-650-012024-07-09
00817183020769StimSite Signal BoxAM-1012024-04-29
00817183020417Suction Tubing Set7-510-442019-02-22
00817183020622Suction Tubing Set72-00327-02019-06-19
00817183020776StimSite Activation CardAM-21012023-11-21
00817183020660NEBULAE SRS Tubing Set7-510-572023-02-14
00817183020684NEBULAE SRS Laparoscopic Surgical Pump7-700-002023-02-14
00817183020714N/A7220399572-00273-02021-01-05
00817183020721N/A720597272-00166-02021-01-05
00817183020738N/A427072-00146-02021-01-05
00817183020196CO2 Hose and Yoke7-510-092016-10-13
00817183020202CO2 Hose and Yoke Shuttle Valve System7-510-502016-10-13
00817183020257CO2 Hose and DISS7-510-342016-10-14
00817183020264CO2 Hose and DIN7-510-362016-10-14
00817183020226Insufflation Tubing, Laparoscopic7-510-522016-10-13
00817183020301Insufflation Tubing, Gen Use 15mm7-510-152016-10-14

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