FDA.reportPublic FDA data

Millennium

Primary DI
00190776408367
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-SU11300027
Device description
"Ochsner Gall Bladder Trocar, 6"", 27fr"
Published
2025-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776408367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776408367001907764083671907764083670190776408367

GMDN Terms#

Term, Definition table
TermDefinition
Suprapubic catheter introducer, reusableA rigid surgical instrument(s) intended to gain percutaneous suprapubic access to the urinary bladder, via the lower abdominal wall, for placement of a drainage catheter (not included). It includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve, and 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
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
00190776437176Millennium1-212EB2026-10-28
00190776437183Millennium1-268EB2026-10-28
00190776437190Millennium1-269EB2026-10-28
00190776437206Millennium1-270-11EB2026-10-28
00190776437213Millennium1-293EB2026-10-28
00190776437220Millennium1-244EB2026-10-28
00190776439811Millenium85-140190932026-10-28
00190776439828Millenium85-710188352026-10-28
00190776439835Millenium85-640033142026-10-28
00190776433796Millennium1-6570502026-10-08
00190776433802Millennium1-6570512026-10-08
00190776433819Millennium1-6570532026-10-08
00190776399221Millennium1-1124282025-05-29
00190776433000Millennium1-161962026-10-26
00190776437060Millennium1-121219-122026-10-26
00190776437077Millennium1-410324C2026-10-26
00190776437084Millennium1-516410-6752026-10-26
00190776437091Millennium1-516420-6752026-10-26
00190776437107Millennium1-516430-6752026-10-26
00190776437114Millennium1-516440-6752026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436834MillenniumAvalign Technologies, Inc.MDM2026-10-22
07540277009663RMAC Surgical MarkerRMAC Surgical, IncMDM2026-10-21
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28