FDA.reportPublic FDA data

Avalign

Primary DI
00190776048532
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM104-8187
Device description
Sinus Through-Cutting Forcep
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
KAEFORCEPS, ENT

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776048532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776048532001907760485321907760485320190776048532

GMDN Terms#

Term, Definition table
TermDefinition
Tonsil punch forcepsA hand-held manual surgical instrument with a cutting/biting action intended to be used for the removal of the tonsils during a tonsillectomy. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the tonsil 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
00190776432256Millennium1-9317432026-09-24
00190776432263Millennium1-7023075732026-09-24
00190776432270Millennium1-7023075742026-09-24
00190776432287Millennium1-2245100402026-09-24
00190776432294Millennium1-2810170002026-09-24
00190776432300Millennium100-S03285FGD202026-09-24
00190776432317Millennium100-S03286FGD452026-09-24
00190776432324Millennium72-586006C2026-09-24
00190776432331Millennium1-831100202026-09-24
00190776432348Millennium72-52515962026-09-24
00190776432355Millennium1-9314972026-09-24
00190776432362Millennium1-4751872026-09-24
00190776432379Millennium1-CH26102026-09-24
00190776432386Millennium72-52103236C32026-09-24
00190776432393Millennium72-241180KB2026-09-24
00190776432409Millennium1-CP4520022026-09-24
00190776432416Millennium72-52505182026-09-24
00190776432423Millennium1-GS4259402026-09-24
00190776432430Millennium100-S02681TR2026-09-24
00190776432447Millennium100-S02683TR2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267926Snowden-PencerSTERIS Deutschland GmbHKAE2026-09-25
00724995271466V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995274955V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275013V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275020V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275037V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275044V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275051V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275068V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275075V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995330002V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
04046826110932MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2026-09-24
G141550875300Carnegie Surgical LLCCarnegie Surgical LLCKAE2026-09-19
00190776420413MillenniumAvalign Technologies, Inc.KAE2026-08-26
00190776420420MillenniumAvalign Technologies, Inc.KAE2026-08-26
04054462901692evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901708evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901715evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901722evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901739evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901746evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901760evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901807evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903160evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903177evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903184evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903191evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903207evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905591evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905607evonosevonos GmbH & Co. KGKAE2026-08-21