FDA.reportPublic FDA data

Avalign

Primary DI
00190776067786
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM82-6536
Device description
Yasargil Microvascular Scissor
Published
2021-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZXINSTRUMENT, MICROSURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776067786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776067786001907760677861907760677860190776067786

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical scissorsA hand-held manual surgical instrument designed to cut tissue (e.g., dura mater, neural soft-tissue) during neurosurgery. It comprises two hinged blades of micro design that cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04058749002157NAFehling Instruments GmbH & Co. KGGZX2026-01-28
00192896122130Avian Set With TraySONTEC INSTRUMENTS, INC.GZX2025-09-26
04058749013801NAFehling Instruments GmbH & Co. KGGZX2025-08-29
00194613077624MSI Precision Specialty InstrumentsMed Saver, Inc.GZX2025-08-01
00194613077631MSI Precision Specialty InstrumentsMed Saver, Inc.GZX2025-08-01
00194613077648MSI Precision Specialty InstrumentsMed Saver, Inc.GZX2025-08-01
00888118145901SCISSORSKLS-Martin L.P.GZX2025-05-26
00888118145918SCISSORSKLS-Martin L.P.GZX2025-05-26
00888118146007DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146014DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146021DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146038DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146045DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146052DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146069DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146076DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146083DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146090DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146106DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146113DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146120DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146137DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146144DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146151DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146168DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146175DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146182DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146199DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146205DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146212DISSECTORKLS-Martin L.P.GZX2025-05-26