FDA.reportPublic FDA data

Avalign

Primary DI
00190776219499
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM101-3269
Device description
Mini McGee Forcep, Straight
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
KAEFORCEPS, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776219499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776219499001907762194991907762194990190776219499

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

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
09348811103338INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-16
09348811103321INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-09
24026704934472PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934489PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934502PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934519PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934526PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934533PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934540PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934557PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934571PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934588PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934625PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934632PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
00810123209842Adler Instrument CompanyAdler, Inc.KAE2026-03-03
00190776417413MillenniumAvalign Technologies, Inc.KAE2026-02-27
00190776417468MillenniumAvalign Technologies, Inc.KAE2026-02-27
00848657078214AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAE2026-02-18
00848657078221AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAE2026-02-18
09008737448905SoftGrip Forceps 2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
09008737448912SoftGrip Forceps SR2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
G04362076B0BEARBear-Ent, LLCKAE2026-02-03
09348811103659INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-01-28
09348811103673INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-01-28
04046826104276Medicon ForcepsMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2025-12-15
09348811105424INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-02
09348811129017INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-02
09348811104199INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
09348811104229INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
09348811104328INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01