FDA.reportPublic FDA data

Avalign

Primary DI
00190776041281
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM56-4431
Device description
Blake Gall Stone Forcep
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
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776041281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776041281001907760412811907760412810190776041281

GMDN Terms#

Term, Definition table
TermDefinition
Gallstone scoopA hand-held manual surgical instrument designed for the removal of gallstones. It is typically made of high-grade stainless steel and has a very long, thin, malleable (bendable) working end that terminates in a small spoon-like scoop. At the proximal end is a handle used by the surgeon to manipulate and operate the instrument during the removal procedure. It can have a variety of scoop 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
00766588420103Forceps - MagnifierCertified Safety Manufacturing, Inc.HTD2026-05-26
10766588420100Forceps - Magnifier UDI/10Certified Safety Manufacturing, Inc.HTD2026-05-26
00810143907537SURGIPROSSurgipros, LLCHTD2026-05-23
00190776417994MillenniumAvalign Technologies, Inc.HTD2026-03-23
24026704941494PILLINGTELEFLEX INCORPORATEDHTD2026-03-23
24026704941500PILLINGTELEFLEX INCORPORATEDHTD2026-03-23
00192896122857Diamond Head Grasping ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-19
00810158219267PRINCETONPrinceton Medical Group, Inc.HTD2026-03-12
00810158219274PRINCETONPrinceton Medical Group, Inc.HTD2026-03-12
00810158219045PRINCETONPrinceton Medical Group, Inc.HTD2026-03-11
00192896122741Micro Alligator ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-10
00192896122758Brophy Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-10
B382S1350010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382020Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382030Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382040Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382050Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382060Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382100Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382110Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S18382120Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382S9057001000Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD901132120Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD901186250Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018372010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018372040Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382020Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382030Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD90118621C0Surgical DirectSurgical Direct, Inc.HTD2026-02-26