FDA.reportPublic FDA data

Avenir

Primary DI
06970908212840
Brand
Avenir
Company
Shanghai Wallaby Medical Technologies Co., Inc.
Model
10CSW02020
Published
2025-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCGDevice, Neurovascular Embolization
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970908212840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970908212840069709082128406970908212840

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544535295
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970908212079Paragon 8F Balloon Guide CatheteBG8F0852026-04-15
06970908212086Paragon 8F Balloon Guide CatheteBG8F0952026-04-15
06970908212093Paragon 8F Balloon Guide CatheteBG8F0852024-10-11
06970908212109Paragon 8F Balloon Guide CatheteBG8F0952024-10-11
06970908212734Avenir10HSW010082025-01-15
06970908212741Avenir10HSW010102025-01-15
06970908212758Avenir10HSW015102025-01-15
06970908212765Avenir10HSW015152025-01-15
06970908212772Avenir10HSW020122025-01-15
06970908212789Avenir10HSW020202025-01-15
06970908212796Avenir10CSW010082025-01-15
06970908212802Avenir10CSW010102025-01-15
06970908212819Avenir10CSW015102025-01-15
06970908212826Avenir10CSW015152025-01-15
06970908212833Avenir10CSW020122025-01-15
06970908212857Avenir10CSW030202025-01-15
06970908212864Avenir10CSW030302025-01-15
06970908212871Avenir10CSW040302025-01-15
06970908212888Avenir10CSW040402025-01-15
06970908212901Esperance 3+ Aspiration Catheter SystemASP3F133KIT2024-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04546540688897GDC-10Stryker CorporationHCG2015-09-21
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04546540688934GDC-10Stryker CorporationHCG2015-09-21
04546540688958GDC-10Stryker CorporationHCG2015-09-21
04546540689054GDC-10Stryker CorporationHCG2015-09-21
04546540689061GDC-10Stryker CorporationHCG2015-09-21
04546540689078GDC-10Stryker CorporationHCG2015-09-21
04546540689085GDC-10Stryker CorporationHCG2015-09-21
04546540689092GDC-10Stryker CorporationHCG2015-09-21
04546540689108GDC-10Stryker CorporationHCG2015-09-21
04546540689115GDC-10Stryker CorporationHCG2015-09-21
04546540689122GDC-10Stryker CorporationHCG2015-09-21
04546540689139GDC-10Stryker CorporationHCG2015-09-21
04546540689146GDC-10Stryker CorporationHCG2015-09-21
04546540689153GDC-10Stryker CorporationHCG2015-09-21
04546540689160GDC-10Stryker CorporationHCG2015-09-21
04546540689177GDC-10Stryker CorporationHCG2015-09-21
04546540689184GDC-10Stryker CorporationHCG2015-09-21
04546540689191GDC-10Stryker CorporationHCG2015-09-21
04546540689207GDC-10Stryker CorporationHCG2015-09-21
04546540689214GDC-10Stryker CorporationHCG2015-09-21
04546540689221GDC-10Stryker CorporationHCG2015-09-21
04546540689238GDC-10Stryker CorporationHCG2015-09-21
04546540689245GDC-10Stryker CorporationHCG2015-09-21
04546540689252GDC-10Stryker CorporationHCG2015-09-21
04546540689269GDC-10Stryker CorporationHCG2015-09-21
04546540689276GDC-10Stryker CorporationHCG2015-09-21
04546540689283GDC-10Stryker CorporationHCG2015-09-21
04546540689290GDC-10Stryker CorporationHCG2015-09-21
04546540689306GDC-10Stryker CorporationHCG2015-09-21