FDA.reportPublic FDA data

Avalign

Primary DI
00190776065027
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM81-8737
Device description
K-style Hook
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
00190776065027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776065027001907760650271907760650270190776065027

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. 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