FDA.reportPublic FDA data

Avalign

Primary DI
00190776068585
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM82-6222
Device description
Needle Diss, semi-sharp, #11
Published
2021-11-03
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
HASNEEDLE, NEUROSURGICAL SUTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HASNeedle, Neurosurgical SutureNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776068585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776068585001907760685851907760685850190776068585

GMDN Terms#

Term, Definition table
TermDefinition
Dura mater dissectorA hand-held surgical instrument, usually softly rounded and curved at the working end, used to separate the outermost membrane covering of the brain and spinal cord from the inner membranes. It is usually designed with a handle which continues into a shaft that terminates at the distal end with a rounded curved tip, or it can be double-ended. It is made of high-grade stainless steel, comes in various shapes and sizes. 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
Premarket exempt
true
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
04262494463051N/ADoppkon GmbH & Co. KGHAS2025-12-04
00887482103579Symmetry Rhoton®ASPEN SURGICAL PRODUCTS, INC.HAS2024-09-05
00887482103593Symmetry Rhoton®ASPEN SURGICAL PRODUCTS, INC.HAS2024-08-01
00190776354619MILLENNIUMAvalign Technologies, Inc.HAS2023-09-28
00190776355067MILLENNIUMAvalign Technologies, Inc.HAS2023-09-28
14026704796929PILLINGTELEFLEX INCORPORATEDHAS2022-12-08
54026704796927PILLINGTELEFLEX INCORPORATEDHAS2022-12-08
00887482096215Symmetry AdsonASPEN SURGICAL PRODUCTS, INC.HAS2022-08-24
00190776068592AvalignAvalign Technologies, Inc.HAS2021-11-03
00190776211912AvalignAvalign Technologies, Inc.HAS2021-11-03
00190660121549Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-07
00190660121556Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-07
00190660109707Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
00190660121563Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
00190660121570Ambler SurgicalAMBLER SURGICAL CORP.HAS2021-01-04
10885403072819V. MuellerSTERIS CORPORATIONHAS2018-08-30