FDA.reportPublic FDA data

Avalign

Primary DI
00190776016067
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM84-2566
Device description
McCulloch Type retractor frame
Published
2017-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776016067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776016067001907760160671907760160670190776016067

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, reusableA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780537533Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537571Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537588Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537625TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537649TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537663TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537670TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537694TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537717TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537724TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537748TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537779Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537816TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537854TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537861TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537878Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537885Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537908MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537915MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537960MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537977MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538004MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538042BUDDE®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538066BUDDE®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780344605Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344612Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344629Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344636Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344643Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344650Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23