FDA.reportPublic FDA data

Avalign

Primary DI
00190776049416
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM105-2231
Device description
Ronis Adenoid Punch, #1,
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
KBSPUNCH, ADENOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBSPunch, AdenoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776049416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776049416001907760494161907760494160190776049416

GMDN Terms#

Term, Definition table
TermDefinition
ENT soft-tissue cutting forcepsA hand-held manual surgical instrument with a biting action intended to be used to punch/cut/excise soft-tissue during an ear/nose/throat (ENT) procedure [e.g., adenoidectomy, tonsillectomy, sinus surgery, septoplasty, and/or biopsy]. It is a metallic instrument with a distal mechanism designed to bite tissue when the handles are squeezed together; some types may be used endoscopically (e.g., through a laryngopharyngoscope), and may include an integrated fluid suction channel for improved surgical field viewing. 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
00190776397029MillenniumAvalign Technologies, Inc.KBS2026-07-22
00190776403393MillenniumAvalign Technologies, Inc.KBS2026-07-21
00190776400446MillenniumAvalign Technologies, Inc.KBS2026-07-17
00757770508709Bausch + LombBausch & Lomb IncorporatedKBS2026-04-30
00757770508723Bausch + LombBausch & Lomb IncorporatedKBS2026-04-30
00757770508693Bausch + LombBausch & Lomb IncorporatedKBS2025-08-07
00757770508716Bausch + LombBausch & Lomb IncorporatedKBS2025-08-07
04049197474801RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKBS2024-09-20
04049197474818RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKBS2024-09-20
00840183509415BR Surgical, LLCBR Surgical, LLCKBS2024-06-03
00840183512408BR Surgical, LLCBR Surgical, LLCKBS2024-06-03
00842331195471Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
G586E8251130Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
G586E8251140Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
G586E8261110Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
G586E8261120Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
G586E8263310Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
00842331194412Novo Surgical Inc. NOVO SURGICAL, INC.KBS2023-12-07
00842331194429Novo Surgical Inc. NOVO SURGICAL, INC.KBS2023-12-07
00190776327132MillenniumAvalign Technologies, Inc.KBS2023-06-23
00842962149591HNM MEDICALHNM STAINLESS, LLC.KBS2023-04-06
00842962149607HNM MEDICALHNM STAINLESS, LLC.KBS2023-04-06
00842962149614HNM MEDICALHNM STAINLESS, LLC.KBS2023-04-06
00840319742846Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742853Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742860Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742877Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742884Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742891Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742907Hayden MedicalHayden Medical, Inc.KBS2023-03-14