FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776325060
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
2-2991C
Device description
THRUBITE Blakesly Punch
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
KTFPUNCH, ENT

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776325060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776325060001907763250601907763250600190776325060

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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

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
00190776402624MillenniumAvalign Technologies, Inc.KTF2025-06-24
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