FDA.reportPublic FDA data

Valleylab

Primary DI
10884524000428
Brand
Valleylab
Company
Covidien LP
Model
E0520
Device description
Trigger Switch and Cord
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K970140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970140000E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCHValleylab, Inc.1997-03-28GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884524000425PackageGS110Not in Commercial Distribution
10884524000428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452400042520884524000425
1088452400042810884524000428

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Feet

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-29 Degrees Fahrenheit149 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521705166SofsilkSS622G2017-06-27
10884521757714Maxon8886616523-22020-07-19
10884521099272Chemosite1200492015-10-22
10884521099289Chemosite1200892015-09-28
10884521099265Chemosite1200392015-10-22
10884521852273BIS AdvancePMC80CB2026-10-26
10884521783829LigaSureMRASILF192026-10-23
10884521853812Shiley1108602026-10-25
10884521853829Shiley1108652026-10-25
10884521853836Shiley1108702026-10-25
10884521853843Shiley1108752026-10-25
10884521853850Shiley1108802026-10-25
10884521853867Shiley1108852026-10-25
10884521853874Shiley1108902026-10-25
10884521856547Touch SurgeryMDS300282026-10-23
10884521861114Vital SyncVITALSYNCSW032026-10-25
10884521039902Surgipro llVPF-703-MX2015-09-02
10884521063433Ti-CronX-11362015-09-02
10884521073951Versaport PlusNB8STF2016-09-24
10884521195677Surgipro IIVP-653-MX2015-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841019124178KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-28
00841019124161KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00841019124239KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-27
00190776439774MilleniumAvalign Technologies, Inc.GEI2026-10-26
10884521783829LigaSureCovidien LPGEI2026-10-23
00190776436858MillenniumAvalign Technologies, Inc.GEI2026-10-22
B382SD77105560Surgical DirectSurgical Direct, Inc.GEI2026-10-22
00190776435752MillenniumAvalign Technologies, Inc.GEI2026-10-21
00190776435769MillenniumAvalign Technologies, Inc.GEI2026-10-21
00841019124192KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-21
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDGEI2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
00190776435288MillenniumAvalign Technologies, Inc.GEI2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16