FDA.reportPublic FDA data

Millennium

Primary DI
00190776297473
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-23104510
Device description
Irrigation Cannula with 4 holes, stopcock, luer lock connection
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
NBHAccessories, arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776297473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776297473001907762974731907762974730190776297473

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. 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
00190776432256Millennium1-9317432026-09-24
00190776432263Millennium1-7023075732026-09-24
00190776432270Millennium1-7023075742026-09-24
00190776432287Millennium1-2245100402026-09-24
00190776432294Millennium1-2810170002026-09-24
00190776432300Millennium100-S03285FGD202026-09-24
00190776432317Millennium100-S03286FGD452026-09-24
00190776432324Millennium72-586006C2026-09-24
00190776432331Millennium1-831100202026-09-24
00190776432348Millennium72-52515962026-09-24
00190776432355Millennium1-9314972026-09-24
00190776432362Millennium1-4751872026-09-24
00190776432379Millennium1-CH26102026-09-24
00190776432386Millennium72-52103236C32026-09-24
00190776432393Millennium72-241180KB2026-09-24
00190776432409Millennium1-CP4520022026-09-24
00190776432416Millennium72-52505182026-09-24
00190776432423Millennium1-GS4259402026-09-24
00190776432430Millennium100-S02681TR2026-09-24
00190776432447Millennium100-S02683TR2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776431495MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776432119MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776431136MillenniumAvalign Technologies, Inc.NBH2026-09-21
00190776431143MillenniumAvalign Technologies, Inc.NBH2026-09-21
00190776427160MillenniumAvalign Technologies, Inc.NBH2026-08-21
00190776427177MillenniumAvalign Technologies, Inc.NBH2026-08-21
00198506094170ELMED INCORPORATEDELMED INCORPORATEDNBH2026-08-18
07630345716743SportsMed InstrumentsMedacta International SANBH2026-08-17
07630345716750SportsMed InstrumentsMedacta International SANBH2026-08-17
B382SD319590Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD480084LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD48008SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481014SLH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481022LH0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752CBDYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481752PT0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481755STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481756STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD481760DYN0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD483003STR0Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487193000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD487223000Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD5235320Surgical DirectSurgical Direct, Inc.NBH2026-08-03
B382SD142090Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD1814DK70Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD18252590Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD30609CH0Surgical DirectSurgical Direct, Inc.NBH2026-07-31
B382SD316390Surgical DirectSurgical Direct, Inc.NBH2026-07-31
00198506093258ELMED INCORPORATEDELMED INCORPORATEDNBH2026-07-28
00810143908534SURGIPROSSurgipros, LLCNBH2026-07-28