FDA.reportPublic FDA data

Avalign

Primary DI
00190776048242
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM104-6700
Device description
Micro Backbiter
Published
2021-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTFPUNCH, ENT

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776048242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776048242001907760482421907760482420190776048242

GMDN Terms#

Term, Definition table
TermDefinition
Adenoid punch forcepsA hand-held manual surgical instrument with a cutting/biting action intended to be used for excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is a metallic alligator-forceps-like instrument, often with a curved shaft, and with a distal mechanism designed to bite/punch adenoid tissue when the handles are squeezed together. It is not intended for cutting bone (i.e., not a rongeur). 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
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462900404evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905829evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905843evonosevonos GmbH & Co. KGKTF2026-08-18
04054462905850evonosevonos GmbH & Co. KGKTF2026-08-18
04054462908912evonosevonos GmbH & Co. KGKTF2026-08-18
04054462915163evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915170evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915187evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915194evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915200evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915217evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915224evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915231evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915248evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915255evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915262evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915279evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915286evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915293evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915309evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915316evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915323evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915347evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915354evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915361evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915378evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915385evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915392evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915408evonosevonos GmbH & Co. KGKTF2026-08-17
04054462915415evonosevonos GmbH & Co. KGKTF2026-08-17