FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776329402
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
9-128390
Device description
Lowsley Prostatic Tractor, curved,
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGNRETRACTOR, NON-SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776329402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776329402001907763294021907763294020190776329402

GMDN Terms#

Term, Definition table
TermDefinition
Externally-anchored laparoscopic retractorA non-sterile, intraoperative surgical instrument designed for use during laparoscopic procedures to provide hands-free retraction of lower abdominal, urogenital or pelvic structures. It is inserted into the abdominal cavity through a small dedicated incision and manoeuvred into place under direct laparoscopic vision to lift the urogenital structures, and then anchored external to the body to a fixation device typically attached to the operating table. It is typically made of metal (e.g., stainless steel) and is in the form of a rod shaped to form a saddle-shaped hook, and may be available in left and right configurations. This is a reusable device intended to be sterilized prior to use.

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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811019394INKAThe Trustee for KAISER FAMILY TRUSTFGN2025-11-19
09348811019400INKAThe Trustee for KAISER FAMILY TRUSTFGN2025-11-19
07898506814732QuinelatoSchobell Industrial LtdaFGN2023-01-09
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-10-23
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269397Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269427Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269489Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269564Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269663Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269670Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269694Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269724Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269748Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269762Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269779Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780269816Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780270256Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780268413Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268444Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268451Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268468Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268475Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268482Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268505Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268512Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268529Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268543Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268550Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23