ProCol Biologic Vascular Graft - ProCol Biologic Vascular Graft, 6mm x 30 cm - Lemaitre Vascular, Inc.

Duns Number:184805166

Device Description: ProCol Biologic Vascular Graft, 6mm x 30 cm

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More Product Details

Catalog Number

HJL016-30-N

Brand Name

ProCol Biologic Vascular Graft

Version/Model Number

HJL016-30-N

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"

-

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

P020049

Product Code Details

Product Code

LXA

Product Code Name

Tissue Graft Of 6mm And Greater

Device Record Status

Public Device Record Key

b481ecb2-f06f-4265-8353-0684a69649a9

Public Version Date

April 21, 2021

Public Version Number

5

DI Record Publish Date

March 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LEMAITRE VASCULAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 453
3 A medical device with high risk that requires premarket approval 22