FDA.reportPublic FDA data

Valleylab

Primary DI
30884521767953
Brand
Valleylab
Company
Covidien LP
Model
E3583-28
Catalog number
E3583-28
Device description
Laparoscopic Argon Blunt Needle Electrode Retractable
Published
2020-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521767956PackageGS110In Commercial Distribution
30884521767953PackageGS1150In Commercial Distribution
10884521767959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452176795620884521767956
3088452176795330884521767953
1088452176795910884521767959

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced endoscopic electrosurgical electrode, single-useA sterile, invasive, distal component of an argon-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of argon (Ar) gas directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within an Ar gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length28Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-22 Degrees Fahrenheit140 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Keep dry;
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit104 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521091986NellcorSC-A-I2026-05-25
20884521841724Shiley50FXLTCP2026-03-17
20884521841687Shiley50FXLTCD2026-03-16
20884521841694Shiley60FXLTCD2026-03-16
20884521841700Shiley70FXLTCD2026-03-16
20884521841717Shiley80FXLTCD2026-03-16
20884521841731Shiley60FXLTCP2026-03-16
20884521841748Shiley70FXLTCP2026-03-16
20884521841755Shiley80FXLTCP2026-03-16
20884521841762Shiley50FXLTUD2026-03-16
20884521841779Shiley60FXLTUD2026-03-16
20884521841786Shiley70FXLTUD2026-03-16
20884521841793Shiley80FXLTUD2026-03-16
20884521841809Shiley50FXLTUP2026-03-16
20884521841816Shiley60FXLTUP2026-03-16
20884521841823Shiley70FXLTUP2026-03-16
20884521841830Shiley80FXLTUP2026-03-16
30884521841844Shiley50FXLTIN2026-03-16
20884521841854Shiley60FXLTIN2026-03-16
20884521841861Shiley70FXLTIN2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850067560316LaproSacSurgical Principals, IncGEI2026-05-22
ESUM3644100SutterSutter Medizintechnik GmbHGEI2026-05-22
00845854035590CONCEPTConmed CorporationGEI2026-03-24
00190776417932MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776417956MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418076MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418281MillenniumAvalign Technologies, Inc.GEI2026-03-23
00653405013924CONMEDConmed CorporationGEI2026-03-23
00198506089732ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
00198506089749ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
08800020101525POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108166DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108173DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108180DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108197DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108203DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108289DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108272DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108296DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108302DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108319DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108326DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108395POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108401POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108425POTENZAJeisys Medical Inc.GEI2026-03-16
00198506089565ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-13
10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
10884450587802STAR™Merit Medical Systems, Inc.GEI2026-03-11
08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09