FDA.reportPublic FDA data

Valleylab

Primary DI
20884524000999
Brand
Valleylab
Company
Covidien LP
Model
E7508
Catalog number
E7508
Device description
REM Polyhesive (TM) Adult Cordless Patient Return Electrode
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K822572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822572000POLYHESIVE PATIENT RETURN ELECTRODEValleylab, Inc.1982-09-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884524000999PackageGS1100In Commercial Distribution
10884524000992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452400099920884524000999
1088452400099210884524000992

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Keep dry;

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

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