FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776293154
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
85-2010023
Device description
Drill Bit QC/AO
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
HTWBIT, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776293154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776293154001907762931541907762931540190776293154

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy drill bitA shaft of metal designed to excise (cut out) a small section of bone or cartilage for microscopic examination. It is mounted into a surgical drilling device, either manual or powered, and when rotated at an appropriate speed will perform the required operation. 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
00190776436827Millennium72-3130082OLY2026-10-22
00190776436834Millennium1-1211272026-10-22
00190776436841Millennium63-AOCOMES2026-10-22
00190776436858Millennium100-S03420NSR2026-10-22
00190776436865Millennium1-5255722026-10-22
00190776436872Millennium1-2952026-10-22
00190776436889Millennium1-5053282026-10-22
00190776436896Millennium1-5165062026-10-22
00190776423070Millennium72-4712050SE2026-10-21
00190776435615Millennium72-B9920FADSW2026-10-21
00190776435622Millennium72-B9910FADSW2026-10-21
00190776435639Millennium1-5109332026-10-21
00190776435646Millennium1-5054322026-10-21
00190776435653Millennium72-3295803E2026-10-21
00190776435660Millennium72-1832032026-10-21
00190776435677Millennium72-5225549I2026-10-21
00190776435684Millennium72-31300422026-10-21
00190776435691Millennium1-6158INS2026-10-21
00190776435707Millennium63-5046912026-10-21
00190776435714Millennium63-G120312026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886913330Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HTW2026-10-15
00889795150141APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150158APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150165APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150172APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150189APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150196APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150202APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150219APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150226APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150233APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150240APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150257APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795151728APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00190446960324DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960331DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960348DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960409DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00190446960416DYNANAIL HELIXMedshape, Inc.HTW2026-10-09
00889024715271Affixus®Zimmer, Inc.HTW2026-10-06
10886982345431VOLTSynthes GmbHHTW2026-09-25
10886982345479VOLTSynthes GmbHHTW2026-09-25
00888867574540Arthrex®ARTHREX, INC.HTW2026-09-18
00888867574557Arthrex®ARTHREX, INC.HTW2026-09-18
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
00884450681381Preston™Merit Medical Systems, Inc.HTW2026-08-21
00884450681398Preston™Merit Medical Systems, Inc.HTW2026-08-21