FDA.reportPublic FDA data

Valleylab

Primary DI
10884524001654
Brand
Valleylab
Company
Covidien LP
Model
E6008
Device description
Monopolar Footswitch
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWAUNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWAUnit, Electrosurgical And Coagulation, With AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884524001654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452400165410884524001654

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521072602V-LocVLOCN204L2015-09-02
20884521126852Sofsilk1700022016-09-24
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089473ELMED INCORPORATEDELMED INCORPORATEDBWA2026-04-02
00198506088889ELMED INCORPORATEDELMED INCORPORATEDBWA2026-03-03
00198506084294ELMED INCORPORATEDELMED INCORPORATEDBWA2025-07-29
00198506053887ELMED INCORPORATEDELMED INCORPORATEDBWA2025-07-24
00198506054242ELMED INCORPORATEDELMED INCORPORATEDBWA2025-07-17
00198506053955ELMED INCORPORATEDELMED INCORPORATEDBWA2025-05-09
00198506064494ELMED INCORPORATEDELMED INCORPORATEDBWA2024-10-22
00198506064883ELMED INCORPORATEDELMED INCORPORATEDBWA2024-10-22
00198506061875ELMED INCORPORATEDELMED INCORPORATEDBWA2024-09-25
00198506060717ELMED INCORPORATEDELMED INCORPORATEDBWA2024-08-26
00842180175884ELMEDELMED INCORPORATEDBWA2023-08-11
00842180152908ELMEDELMED INCORPORATEDBWA2023-01-10
00842180156760ELMEDELMED INCORPORATEDBWA2023-01-09
10884521766662ValleylabCovidien LPBWA2021-04-08
00842180137004ELMEDELMED INCORPORATEDBWA2020-08-18
00842180136915ELMEDELMED INCORPORATEDBWA2020-06-17
B382SD84850Surgical DirectSurgical Direct, Inc.BWA2020-04-29
00842180136724ELMEDELMED INCORPORATEDBWA2020-03-05
00842180136519ELMEDELMED INCORPORATEDBWA2019-11-06
00842180136472ELMEDELMED INCORPORATEDBWA2019-10-23
00842180135888ELMEDELMED INCORPORATEDBWA2019-04-09
00842180135833ELMEDELMED INCORPORATEDBWA2019-03-06
00842180135208ELMEDELMED INCORPORATEDBWA2018-10-01
00842180135178ELMEDELMED INCORPORATEDBWA2018-08-17
00842180111974ELMEDELMED INCORPORATEDBWA2018-03-07
00842180107946ELMEDELMED INCORPORATEDBWA2017-04-25
00842180106796ELMEDELMED INCORPORATEDBWA2016-12-28
00842180106802ELMEDELMED INCORPORATEDBWA2016-12-28
00842180106192ELMEDELMED INCORPORATEDBWA2016-10-25
00842180106208ELMEDELMED INCORPORATEDBWA2016-10-25