VenaSeal

Primary DI
10884521539921
Brand
VenaSeal
Company
Covidien LP
Model
VS-402
Device description
VenaSeal Closure System
Published
2015-03-12
Public version status
Update
Distribution status
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
PJQAgent, Occluding, Vascular, Permanent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJQAgent, Occluding, Vascular, PermanentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140018000VENASEAL CLOSURE SYSTEMMedtronic Vascular, Inc.2015-02-20PJQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521539928PackageGS15In Commercial Distribution
10884521539921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452153992820884521539928
1088452153992110884521539921

GMDN Terms#

Term, Definition table
TermDefinition
Varicose vein adhesive-treatment kitA collection of sterile devices intended to be used for the endovascular closure of the great saphenous vein (GSV) and associated varicosities as a treatment for varicose veins. It typically includes a surgical adhesive (e.g., cyanoacrylate), syringe, delivery catheter, dilator, introducer and a dispensing gun. The adhesive is typically delivered under ultrasonic control at prescribed intervals throughout the length of the affected vein to adhere the vessel walls together, resulting in the complete and permanent closure of the lumen. This is a single-use device.

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10884521085329SofsilkGSJ-36-M2015-09-01
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10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
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10884523000627SILSSILSHOOK362016-09-24
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10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000240776VenaSealâ„¢MEDTRONIC, INC.PJQ2021-02-08
00643169986268VenaSealâ„¢MEDTRONIC, INC.PJQ2018-02-25
20643169986262VenaSealâ„¢MEDTRONIC, INC.PJQ2018-02-25