FDA.reportPublic FDA data

NA

Primary DI
00724995151850
Brand
NA
Company
Corporation Steris Canada
Model
PR701480
Catalog number
PR701480
Device description
The Laparoscopic Insulation Tester checks the integrity of the insulation on laparoscopic instruments. This unit is intended to verify insulation integrity on laparoscopic instruments.
Published
2016-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120416000INSULATION TESTERSpectrum Surgical Supply Corp.2012-03-27GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995151850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995151850007249951518507249951518500724995151850

GMDN Terms#

Term, Definition table
TermDefinition
Multi-parameter device testerA battery-powered electronic device designed to measure two or more parameters (e.g., temperature, conductivity, pressure, pH, flow) to calibrate or test a medical device (e.g., haemodialysis equipment, anaesthesia machine, suction system, ophthalmic laser). It typically consists of a hand-held electronic box with appropriate connections and a digital display; dedicated measuring devices (e.g., probe, sensor, electrode, buffer solution) are typically included. It is not dedicated to a specific clinical discipline and is intended to be used by a professional in a professional setting (e.g., clinical engineering).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
202659140
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995094119NAC1201EC1201E2020-09-25
00724995094126NAC1221EC1221E2020-09-25
00724995094133NAC1141EC1141E2020-09-25
00724995090753NAC1202EC1202E2020-06-29
00724995090777NAC1222EC1222E2020-06-29
00724995090791NAC1142EC1142E2020-06-29
00724995090739NAC1160EC1160E2020-01-02
00724995090746NAC1200EC1200E2020-01-02
00724995090760NAC1220EC1220E2020-01-02
00724995090784NAC1140EC1140E2020-01-02
00724995157449NAC3000XLC3000XL2020-01-02
00724995170554SYSTEM 1 endo1 endoP69002019-10-04
00724995092986SYSTEM 1E Liquid Chemical Sterilant Processing System1E65002016-09-13
00724995196042AMSCO5052FH14042S0012020-09-04
00724995216504NAReliance 6000 ConnectorsRECT1CON7P2026-01-14
00724995151416NAMB000010MB0000102016-09-13
00724995151423NAMB000015MB0000152016-09-13
00724995194420NAFlow Unit 11EPSC011INT2020-04-30
00724995001544NAFlow Unit 8EPSC008INT2016-09-13
00724995001551NAFlow Unit 9EPSC009INT2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07
08800017100920VIVACE Microneedle Cartridgeshenb Co., Ltd.GEI2026-08-07
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28