FDA.reportPublic FDA data

Avalign

Primary DI
00190776211301
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM83-4146
Device description
Hardy Type Mirror,
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
00190776211301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776211301001907762113011907762113010190776211301

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgery mirrorA reflective device designed to be used to assist practitioners during general/plastic surgery by displaying the image of an object placed before it.

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
00190776411084Millennium85-780816802026-08-07
00190776411091Millennium85-590091642026-08-07
00190776411107Millennium85-428459942026-08-07
00190776411473Millennium85-420410542026-08-07
00190776411480Millennium85-720471982026-08-07
00190776411497Millennium85-510046232026-08-07
00190776411503Millennium85-320020492026-08-07
00190776411510Millennium85-520016892026-08-07
00190776411527Millennium85-520062662026-08-07
00190776411534Millennium85-400463172026-08-07
00190776411541Millennium85-650098522026-08-07
00190776411558Millennium85-650123692026-08-07
00190776411565Millennium85-170121992026-08-07
00190776411572Millennium85-210785222026-08-07
00190776411589Millennium85-600016902026-08-07
00190776423544Millennium1-263T2026-08-07
00190776423551Millennium63-G122582026-08-07
00190776423568Millennium72-4535040E2026-08-07
00190776423575Millennium1-1201492026-08-07
00190776423582Millennium1-43098252026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408640MillenniumAvalign Technologies, Inc.GZX2026-08-03
00190776407407MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407414MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776422271MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407322MillenniumAvalign Technologies, Inc.GZX2026-07-28
00190776404093MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404116MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404123MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404130MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404086MillenniumAvalign Technologies, Inc.GZX2026-07-22
00190776400613MillenniumAvalign Technologies, Inc.GZX2026-07-21
00190776403386MillenniumAvalign Technologies, Inc.GZX2026-07-21
00650551006978PMT® SUCTION INSTRUMENTSPMT CORPORATIONGZX2026-07-20
00190776402099MillenniumAvalign Technologies, Inc.GZX2026-07-19
00190776400408MillenniumAvalign Technologies, Inc.GZX2026-07-17
00190776400415MillenniumAvalign Technologies, Inc.GZX2026-07-17
00190776395681MillenniumAvalign Technologies, Inc.GZX2026-07-14
00846159039672SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039689SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039696SCANLAN® ScissorsSCANLAN INTERNATIONAL INCGZX2026-05-27
04250418753395Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753401Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753418Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753425Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753432Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753449Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753296Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753302Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753319Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753326Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02