FDA.reportPublic FDA data

Avalign

Primary DI
00190776055738
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM76-2983
Device description
Varady Extractor
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWBEXTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776055738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776055738001907760557381907760557380190776055738

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. 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
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
10705034535364NADEPUY SPINE, LLCHWB2019-02-12
10705034535821NADEPUY SPINE, LLCHWB2019-02-12
10705034533650NADEPUY SPINE, LLCHWB2019-01-16
10705034533667NADEPUY SPINE, LLCHWB2019-01-16
10705034533674NADEPUY SPINE, LLCHWB2019-01-16
10705034533681NADEPUY SPINE, LLCHWB2019-01-16
10705034533698NADEPUY SPINE, LLCHWB2019-01-16
10705034533704NADEPUY SPINE, LLCHWB2019-01-16
10705034533711NADEPUY SPINE, LLCHWB2019-01-16
10705034533728NADEPUY SPINE, LLCHWB2019-01-16
10705034533735NADEPUY SPINE, LLCHWB2019-01-16
10705034533742NADEPUY SPINE, LLCHWB2019-01-16
10705034534060NADEPUY SPINE, LLCHWB2019-01-16
10705034534152NADEPUY SPINE, LLCHWB2019-01-16
10705034534169NADEPUY SPINE, LLCHWB2019-01-16
10705034497754N/ADEPUY SPINE, LLCHWB2018-11-05
10603295080763NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295087861NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295087878NADEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295090595GLOBAL APDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295090649GLOBAL APDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295156017RECLAIMDEPUY (IRELAND)HWB2018-09-24
10603295159087LPSDEPUY ORTHOPAEDICS, INC.HWB2018-09-24
10603295171669S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295171676S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295171683S-ROMDEPUY (IRELAND)HWB2018-09-24
10603295178408NADEPUY (IRELAND)HWB2018-09-24
10603295181651S-ROM NOILESDEPUY (IRELAND)HWB2018-09-24
10603295248439SPECIALISTDEPUY (IRELAND)HWB2018-09-24