FDA.reportPublic FDA data

Millennium

Primary DI
00190776405953
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-77080380
Device description
Tendon Stripper, 6mm inner diameter
Published
2026-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRTStripper, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRTStripper, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776405953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776405953001907764059531907764059530190776405953

GMDN Terms#

Term, Definition table
TermDefinition
Tendon stripperA hand-held manual surgical instrument designed to excise a length of ligament, tendon or fascia for use as a living graft. It typically consists of a handle and a semicircular shaped trough that terminates in a sharp cutting edge. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18772891096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776435479Millennium1-510489L2026-10-20
00190776435486Millennium1-FK177R2026-10-20
00190776435493Millennium72-5255006452026-10-20
00190776435509Millennium1-3910152026-10-20
00190776435516Millennium1-750750202026-10-20
00190776435523Millennium1-750750402026-10-20
00190776435530Millennium1-636012026-10-20
00190776435547Millennium72-5255540SL2026-10-20
00190776435554Millennium1-9356482026-10-20
00190776435561Millennium72-522056116202026-10-20
00190776435578Millennium1-225402L2026-10-20
00190776435585Millennium1-225402R2026-10-20
00190776435592Millennium1-6020222026-10-20
00190776435608Millennium1-6020172026-10-20
00190776436612Millenium85-630049412026-10-20
00190776436629Millenium85-110109462026-10-20
00190776436636Millenium85-520062822026-10-20
00190776436643Millenium85-520029442026-10-20
00190776436674Millenium85-420339012026-10-20
00190776436681Millenium85-520234622026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422899MillenniumAvalign Technologies, Inc.HRT2026-08-03
07613327651164VersiQuadSTRYKER CORPORATIONHRT2026-07-16
10845854087534Infinity™Conmed CorporationHRT2026-06-10
10845854087541Infinity™Conmed CorporationHRT2026-06-10
B7685410360Buxton BioMedicalBUXTON BIOMEDICAL, INC.HRT2026-06-02
05055445944728SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944735SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944742SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944759SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944766SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944773SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944780SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944797SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944827SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05055445944834SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304495SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304501SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111304518SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346211SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346235SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
05056111346242SurtexSURTEX INSTRUMENTS LTD.HRT2026-05-12
00190776419929MillenniumAvalign Technologies, Inc.HRT2026-04-15
00190776419936MillenniumAvalign Technologies, Inc.HRT2026-04-15
00190776416454MillenniumAvalign Technologies, Inc.HRT2026-02-16
00190776416249MillenniumAvalign Technologies, Inc.HRT2026-02-12
00190776416195MillenniumAvalign Technologies, Inc.HRT2026-02-06
04262494463112N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494463129N/ADoppkon GmbH & Co. KGHRT2025-12-04
04262494462542N/ADoppkon GmbH & Co. KGHRT2025-12-02
04262494462566N/ADoppkon GmbH & Co. KGHRT2025-12-02