FDA.reportPublic FDA data

Millennium

Primary DI
00190776402624
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-430221
Device description
PUNCH RONIS CURVED NO 1 Small
Published
2025-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00190776402624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776402624001907764026241907764026240190776402624

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
00190776391560CONDUIT ZERO-P VA4514010602026-07-09
00190776391577CONDUIT ZERO-P VA4514010702026-07-09
00190776391584CONDUIT ZERO-P VA4514010802026-07-09
00190776391591CONDUIT ZERO-P VA4514010902026-07-09
00190776391607CONDUIT ZERO-P VA4514011002026-07-09
00190776391614CONDUIT ZERO-P VA4514011102026-07-09
00190776391621CONDUIT ZERO-P VA4514011202026-07-09
00190776391638CONDUIT ZERO-P VA4514020502026-07-09
00190776391645CONDUIT ZERO-P VA4514020602026-07-09
00190776391652CONDUIT ZERO-P VA4514020702026-07-09
00190776391669CONDUIT ZERO-P VA4514020802026-07-09
00190776391676CONDUIT ZERO-P VA4514020902026-07-09
00190776391553CONDUIT ZERO-P VA4514010502026-07-08
00190776421847Millennium1-3KF-52026-06-25
00190776421694Millennium72-24655152026-06-24
00190776421700Millennium1-1701922026-06-24
00190776421717Millennium1-1701942026-06-24
00190776421724Millennium1-77ST42026-06-24
00190776421731Millennium72-5211303C2026-06-24
00190776421748Millennium1-343003H2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417871MillenniumAvalign Technologies, Inc.KTF2026-03-11
04250676717351Kerrison rongeurSpiggle & Theis Medizintechnik GmbHKTF2025-09-25
00194613029340MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036331MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036355MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036379MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036386MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613036393MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613111533MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00194613123741MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-08-01
00190776402433MillenniumAvalign Technologies, Inc.KTF2025-06-23
00192896121614Circular Cutting PunchSONTEC INSTRUMENTS, INC.KTF2025-06-06
00190776394943MillenniumAvalign Technologies, Inc.KTF2025-05-08
00194613029395MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036324MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036348MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613036362MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613082239MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00194613108045MSI Precision Specialty InstrumentsMed Saver, Inc.KTF2025-03-21
00192896120945Ostrum Antrum PunchSONTEC INSTRUMENTS, INC.KTF2024-12-10
00190776384913MillenniumAvalign Technologies, Inc.KTF2024-08-26
00192896119000Antrum PunchSONTEC INSTRUMENTS, INC.KTF2024-08-26
00192896119024Circular Cutting PunchSONTEC INSTRUMENTS, INC.KTF2024-08-26
00887482118801Symmetry CarleyASPEN SURGICAL PRODUCTS, INC.KTF2024-08-20
00888515134003BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242135BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242142BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515242173BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515243507BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28
00888515243514BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTF2024-02-28