FDA.reportPublic FDA data

ProCol Biologic Vascular Graft

Primary DI
00840663108688
Brand
ProCol Biologic Vascular Graft
Company
Lemaitre Vascular, Inc.
Model
HJL016-40-N
Catalog number
HJL016-40-N
Device description
ProCol Biologic Vascular Graft, 6mm x 40 cm
Published
2016-03-22
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
LXATissue Graft Of 6mm And Greater

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXATissue Graft Of 6mm And GreaterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020049000PROCOL VASCULAR BIOPROSTHESISLeMaitre Vascular, Inc.2003-07-29LXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840663108688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663108688008406631086888406631086880840663108688

GMDN Terms#

Term, Definition table
TermDefinition
Arteriovenous shuntA surgically-implanted device designed to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. It is a synthetic vascular graft/graft assembly with a thin wall and appropriate size (commonly 6 mm diameter) and configuration to facilitate vessel puncturing. It is typically used when it is not possible or convenient to create a direct ateriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7812212266csus@lemaitre.com

Regulatory Flags#

DUNS number
184805166
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840663110360AlboGraft Polyester Vascular Graft ATC6034ATC60342021-06-18
00840663110377AlboGraft Polyester Vascular Graft ATC6038ATC60382021-06-18
00840663110384AlboGraft Polyester Vascular Graft ATC1206ATC12062021-06-18
00840663102815AlboGraft Polyester Vascular GraftAMC1506AMC15062015-07-30
00840663102839AlboGraft Polyester Vascular Graft AMC4006AMC40062015-10-16
00840663102846AlboGraft Polyester Vascular GraftAMC6006AMC60062015-10-16
00840663102853AlboGraft Polyester Vascular GraftAMC1006AMC10062015-10-16
00840663102860AlboGraft Polyester Vascular GraftAMC4007AMC40072015-10-16
00840663102877AlboGraft Polyester Vascular GraftAMC1508AMC15082015-10-16
00840663102884AlboGraft Polyester Vascular GraftAMC3008AMC30082015-10-16
00840663102891AlboGraft Polyester Vascular Graft AMC4008AMC40082015-10-16
00840663102907AlboGraft Polyester Vascular Graft AMC6007AMC60072015-10-16
00840663102914AlboGraft Polyester Vascular Graft AMC6008AMC60082015-10-16
00840663102921AlboGraft Polyester Vascular Graft AMC1008AMC10082015-10-16
00840663102938AlboGraft Polyester Vascular Graft AMC1510AMC15102015-10-16
00840663102945AlboGraft Polyester Vascular Graft AMC3010AMC30102015-10-16
00840663102952AlboGraft Polyester Vascular Graft AMC4010AMC40102015-10-16
00840663102969AlboGraft Polyester Vascular Graft AMC6010AMC60102015-10-16
00840663102976AlboGraft Polyester Vascular Graft AMC1010AMC10102015-10-16
00840663102983AlboGraft Polyester Vascular Graft AMC1512AMC15122015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00316837000367Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2019-07-29
00840663108657ProCol Biologic Vascular GraftLemaitre Vascular, Inc.LXA2016-03-22
00840663108664ProCol Biologic Vascular GraftLemaitre Vascular, Inc.LXA2016-03-22
00840663108671ProCol Biologic Vascular GraftLemaitre Vascular, Inc.LXA2016-03-22
00316837000343Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-30
00316837000190Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000206Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000213Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000220Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000237Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000244Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000251Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000268Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000275Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000282Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000299Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000305Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000312Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000329Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000336Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00316837000350Artegraft Vascular GraftLemaitre Vascular, Inc.LXA2014-08-29
00866271000008ProCol Vascular BioprosthesisHancock Jaffe Laboratories, Inc.LXA2014-08-14
00866271000015ProCol Vascular BioprosthesisHancock Jaffe Laboratories, Inc.LXA2014-08-14
00866271000022ProCol Vascular BioprosthesisHancock Jaffe Laboratories, Inc.LXA2014-08-14
00866271000039ProCol Vascular BioprosthesisHancock Jaffe Laboratories, Inc.LXA2014-08-14