FDA.reportPublic FDA data

Avalign

Primary DI
00190776067670
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM82-6442
Device description
Microvascular Scissor
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
GZXINSTRUMENT, MICROSURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776067670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776067670001907760676701907760676700190776067670

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
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
G223150101200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCGZX2023-06-15
10381780225317Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225447Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225454Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225638Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225393Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-09
10381780194354Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194361Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194378Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194385Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194392Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194408Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194415Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194422Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780167259Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780167273Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185505Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185536Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185543Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185550Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185598Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185604Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185611Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185628Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185666Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185673Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185680Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185697Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185703Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185710Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27