FDA.reportPublic FDA data

Millennium

Primary DI
00190776421885
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-23101245
Device description
Sheath used for Shunt Passer 72-TUN45-SHARP
Published
2026-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWQPasser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWQPasserOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776421885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776421885001907764218851907764218850190776421885

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. 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
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
00190776421854Millennium72-52203222026-07-23
00190776421861Millennium1-751102502026-07-23
00190776421878Millennium72-231012652026-07-23
00190776421892Millennium1-0051L2026-07-23
00190776421908Millennium1-029L2026-07-23
00190776421915Millennium1-HB638132026-07-23
00190776421922Millennium1-137250L2026-07-23
00190776421939Millennium72-3219402EV2026-07-23
00190776421946Millennium72-7151220E2026-07-23
00190776421953Millennium72-9820SS2026-07-23
00190776421977Millennium1-6235BL2026-07-23
00190776421984Millennium1-866452026-07-23
00190776421991Millennium1-1172502026-07-23
00190776422004Millennium1-1172522026-07-23
00190776397029Millennium85-230835662026-07-22
00190776403874Millennium85-760P211392026-07-22
00190776403881Millennium85-900117122026-07-22
00190776403904Millennium85-710186242026-07-22
00190776403911Millennium85-220085422026-07-22
00190776403928Millennium85-100042872026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421878MillenniumAvalign Technologies, Inc.HWQ2026-07-23
00816101010004Flexor Tendon Sheath Retractor and Suture Retriever / Sheath DilatorTOBY ORTHOPAEDICSHWQ2026-04-22
00190776419998MillenniumAvalign Technologies, Inc.HWQ2026-04-15
00190776420000MillenniumAvalign Technologies, Inc.HWQ2026-04-15
10818674022207Suture passeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2026-04-14
10850067560170LaproCloseSurgical Principals, IncHWQ2025-12-11
10850067560187LaproCloseSurgical Principals, IncHWQ2025-12-11
10850067560194LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560173LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560180LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560197LaproCloseSurgical Principals, IncHWQ2025-12-11
00842188130243Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130250Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130267Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130212Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130229Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130236Shuttle PinTrimed, INC.HWQ2025-07-08
00840277409935P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409942P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409959P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
10810128461075AC Slider NeedleT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846117425° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846118125° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846119845° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846120445° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846121190° Tight Curve, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461228Crescent, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461235Straight, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
04047844127964CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27
04047844127971CYLOX STSIGNUS Medizintechnik GmbHHWQ2025-05-27