FDA.reportPublic FDA data

Millennium

Primary DI
00190776296049
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-3140090
Device description
Lithotripsy Working Element Stone Punch - 24 Fr (for use with 4.0 mm scope)
Published
2022-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776296049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776296049001907762960491907762960490190776296049

GMDN Terms#

Term, Definition table
TermDefinition
LithotriteA hand-held manual surgical instrument designed for the mechanical crushing of renal stones (calculi) in the urinary tract and/or bladder. It is typically designed with a sturdy pair of jaws at the distal end that are placed over and crush the stone when the operator applies pressure to the handles at the proximal end; the jaws close, grasp and crush the stone. Some types may employ a screw spindle which the operator can rotate to augment the crushing force. The instrument may be used endoscopically and may include a port for irrigation to provide a clear visual field. This device reflects old technology. 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
00190776397050Millennium85-160P208832026-07-16
00190776397067Millennium85-530366172026-07-16
00190776397074Millennium85-720391422026-07-16
00190776397081Millennium14-50052026-07-16
00190776397104Millennium85-770498932026-07-16
00190776397111Millennium85-230675902026-07-16
00190776397128Millennium85-640041212026-07-16
00190776397135Millennium85-710186192026-07-16
00190776397142Millennium85-300243682026-07-16
00190776397159Millennium85-780096162026-07-16
00190776397166Millennium85-900102152026-07-16
00190776397173Millennium85-520023162026-07-16
00190776397180Millennium85-528137762026-07-16
00190776397197Millennium85-520111272026-07-16
00190776397463Millennium85-140308682026-07-16
00190776398484Millennium85-800001202026-07-16
00190776398651Millennium85-590P015832026-07-16
00190776398668Millennium85-710378692026-07-16
00190776398682Millennium85-710369342026-07-16
00190776398699Millennium85-710374012026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091759ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091810ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091841ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091858ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091889ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091483ELMED INCORPORATEDELMED INCORPORATEDKOA2026-06-09
00850081334040Zenflow Spring® Implant Retrieval DeviceZENFLOW, INC.KOA2026-05-22
00198506090882ELMED INCORPORATEDELMED INCORPORATEDKOA2026-05-15
00190776419288MillenniumAvalign Technologies, Inc.KOA2026-04-14
14026704941619PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
24026704941616PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
00198506089640ELMED INCORPORATEDELMED INCORPORATEDKOA2026-03-17
10198956293243CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00198506088537ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
00198506088599ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
50198956293241CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00190776417307MillenniumAvalign Technologies, Inc.KOA2026-02-20
00198506088155ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-22
00198506087363ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00198506087424ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00190776414351MillenniumAvalign Technologies, Inc.KOA2025-10-23
00198506086151ELMED INCORPORATEDELMED INCORPORATEDKOA2025-10-20
00190776413569MillenniumAvalign Technologies, Inc.KOA2025-10-10
00190776412982MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412999MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412722MillenniumAvalign Technologies, Inc.KOA2025-10-06
00842180149724ELMED INCORPORATEDELMED INCORPORATEDKOA2025-09-30
00190776410360MillenniumAvalign Technologies, Inc.KOA2025-09-11
00190776409562MillenniumAvalign Technologies, Inc.KOA2025-09-03
05996617000050UroDapter®/MID-IIPHARMICO MEDICAL Korlátolt Felelősségű TársaságKOA2025-08-25