VasQ

Primary DI
07290016063325
Brand
VasQ
Company
LAMINATE MEDICAL TECHNOLOGIES LTD
Model
2
Catalog number
FG0032
Device description
External support for vascular access arteriovenous fistulas
Published
2023-11-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QVQExtravascular Support For An Arteriovenous Fistula For Vascular Access

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVQExtravascular Support For An Arteriovenous Fistula For Vascular AccessCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220026000VasQLaminate Medical Technologies , Ltd.2023-09-26QVQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016063325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016063325072900160633257290016063325

GMDN Terms#

Term, Definition table
TermDefinition
Arteriovenous fistula extraluminal mesh-sleeveA non-bioabsorbable, implantable device intended to be used for the extraluminal (external) support of an arteriovenous fistula (AVF) to facilitate viable maturation and patency of the AVF for haemodialysis. It is a metal mesh structure intended to improve the characteristics of the AVF (e.g., luminal uniformity, flow capability, luminal strength/stability) to reduce the risk of failure from adverse events such as thrombosis, intimal hyperplasia, and stenosis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600196773
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016063318VasQ1FG00312023-11-26
07290016063332VasQ3FG00332023-11-26
07290016063349VasQ4FG00342023-11-26
07290016063356VasQ5FG00352023-11-26
07290016063363VasQ6FG00362023-11-26
07290016063370VasQ DMST5 unit packFG00372023-11-26
07290016063387VasQ DMST20 Unit packFG00382023-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290016063318VasQLAMINATE MEDICAL TECHNOLOGIES LTDQVQ2023-11-26
07290016063332VasQLAMINATE MEDICAL TECHNOLOGIES LTDQVQ2023-11-26
07290016063349VasQLAMINATE MEDICAL TECHNOLOGIES LTDQVQ2023-11-26
07290016063356VasQLAMINATE MEDICAL TECHNOLOGIES LTDQVQ2023-11-26
07290016063363VasQLAMINATE MEDICAL TECHNOLOGIES LTDQVQ2023-11-26