VenaSeal™

GUDID 20643169986262

VS-402 VENASEAL CLOSURE SYSTEM X5

MEDTRONIC, INC.

Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit Varicose vein adhesive-treatment kit

Primary Device ID	20643169986262
NIH Device Record Key	5d1f27fd-83f6-4b5b-84ef-daabb4e18d53
Commercial Distribution Status	In Commercial Distribution
Brand Name	VenaSeal™
Version Model Number	VS-402
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Special Storage Condition, Specify	Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169986268 [Primary]
GS1	20643169986262 [Package] Contains: 00643169986268 Package: PK [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140018

FDA Product Code

PJQ	Agent, occluding, vascular, permanent

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2018-02-25

On-Brand Devices [VenaSeal™]

20643169986262	VS-402 VENASEAL CLOSURE SYSTEM X5
00763000240776	CLOSURE SYSTEM VS-404 VENASEAL US EA