FDA.reportPublic FDA data

Valleylab

Primary DI
10884524002552
Brand
Valleylab
Company
Covidien LP
Model
Force Argon II-20
Device description
Argon Gas Delivery Unit II,120 V
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
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964636000FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEMValleylab, Inc.1997-03-11GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884524002552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452400255210884524002552

GMDN Terms#

Term, Definition table
TermDefinition
Argon-enhanced electrosurgical system generatorA mains electricity-powered (AC-powered) component of an argon-enhanced electrosurgical system that serves as a source of argon (Ar) gas and generates a high frequency electrical current in selected radio-frequency (RF) bands between two electrodes to produce heat in tissues for cutting and coagulating during surgery. The argon is delivered via this device and through a connected handpiece unit that ensures that the argon is channelled around the cutting electrode; a process which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Fahrenheit158 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
Serial number
true
Manufacturing date on label
true

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10884521713208EdgeE1455B2016-11-18
10884521713277EdgeE1475X2016-11-18
20884521103631Mallinckrodt5-182372015-08-28
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40884521105578Shiley5-185412018-05-16
10884521543881SigniaSIGMRET2017-07-24
10884521543874SigniaSIGRIG2017-07-31
10884521620254Shiley862342016-09-24
10884521543812SigniaSIGADAPTXL2017-08-08
10884521101098NellcorMAXPACAI2016-09-24
10884521543782SigniaSIGPHANDLE2017-08-08

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