Gelweave™ - Gelweave Gelatin Impregnated Woven Vascular - VASCUTEK LTD

Duns Number:229053087

Device Description: Gelweave Gelatin Impregnated Woven Vascular Prosthesis PRECURVED 4 BRANCH PLEXUS

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More Product Details

Catalog Number

73221088/8SD

Brand Name

Gelweave™

Version/Model Number

73221088/8SD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090987,K162794

Product Code Details

Product Code

DSY

Product Code Name

PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Record Status

Public Device Record Key

ee79069f-209d-4bf6-b988-168de9625acc

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

October 19, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VASCUTEK LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1682
3 A medical device with high risk that requires premarket approval 40