FDA.reportPublic FDA data

Avalign

Primary DI
00190776211912
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM82-62235
Device description
R-Type needle, straight,
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
00190776211912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776211912001907762119121907762119120190776211912

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, reusableA non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. This is a reusable device intended to be sterilized prior to use.

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
00190776435479Millennium1-510489L2026-10-20
00190776435486Millennium1-FK177R2026-10-20
00190776435493Millennium72-5255006452026-10-20
00190776435509Millennium1-3910152026-10-20
00190776435516Millennium1-750750202026-10-20
00190776435523Millennium1-750750402026-10-20
00190776435530Millennium1-636012026-10-20
00190776435547Millennium72-5255540SL2026-10-20
00190776435554Millennium1-9356482026-10-20
00190776435561Millennium72-522056116202026-10-20
00190776435578Millennium1-225402L2026-10-20
00190776435585Millennium1-225402R2026-10-20
00190776435592Millennium1-6020222026-10-20
00190776435608Millennium1-6020172026-10-20
00190776436612Millenium85-630049412026-10-20
00190776436629Millenium85-110109462026-10-20
00190776436636Millenium85-520062822026-10-20
00190776436643Millenium85-520029442026-10-20
00190776436674Millenium85-420339012026-10-20
00190776436681Millenium85-520234622026-10-20

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
00190776068585AvalignAvalign Technologies, Inc.HAS2021-11-03
00190776068592AvalignAvalign 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