AccessGUDID - DEVICE: VenaSeal™ (00643169986268)

GUDID

Device Identifier (DI) Information

Brand Name: VenaSeal™
Version or Model: VS-402
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169986268
Issuing Agency: GS1
Commercial Distribution End Date: December 07, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: VS-402 VENASEAL CLOSURE SYSTEM X5

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58708	Varicose vein adhesive-treatment kit	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJQ	Agent, occluding, vascular, permanent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P140018	006

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5d1f27fd-83f6-4b5b-84ef-daabb4e18d53
Public Version Date: April 20, 2022
Public Version Number: 4
DI Record Publish Date: February 25, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20643169986262	5	00643169986268	2018-12-07	Not in Commercial Distribution	PK

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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