FDA.reportPublic FDA data

Avalign

Primary DI
00190776048600
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM37-2127
Device description
Defourmental Nasal Rongeur,
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
KBBRONGEUR, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBBRongeur, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776048600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776048600001907760486001907760486000190776048600

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. 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
00190776417116Millennium85-170103022026-08-19
00190776417123Millennium85-170103072026-08-19
00190776417130Millennium85-150210582026-08-19
00190776417147Millennium85-200817712026-08-19
00190776417154Millennium85-770057162026-08-19
00190776417161Millennium85-538056882026-08-19
00190776417178Millennium85-320071642026-08-19
00190776417192Millennium85-780866482026-08-19
00190776417208Millennium85-330848342026-08-19
00190776417215Millennium85-330848142026-08-19
00190776417222Millennium85-330848192026-08-19
00190776417239Millennium85-638014582026-08-19
00190776417246Millennium85-230826882026-08-19
00190776417253Millennium85-230811872026-08-19
00190776417710Millennium85-230811922026-08-19
00190776417727Millennium85-124162352026-08-19
00190776426569Millennium1-466322026-08-19
00190776426576Millennium92-F1750T2026-08-19
00190776426583Millennium1-911-52026-08-19
00190776426590Millennium1-910-52026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462910915evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910922evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910939evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910953evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910960evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911011evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911028evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911035evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911042evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911059evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911066evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911073evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911080evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911097evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911103evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911110evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911127evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911134evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911141evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911158evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911165evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911172evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911189evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911196evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911202evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911219evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911226evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911233evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911257evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911264evonosevonos GmbH & Co. KGKBB2026-08-19