FDA.reportPublic FDA data

Millennium

Primary DI
00190776305116
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-128152
Device description
"Leader Vas Hook, 6.25"", Corkscrew Tip"
Published
2023-06-23
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
FHBHOOK, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHBHook, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776305116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776305116001907763051161907763051160190776305116

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. 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
00190776436827Millennium72-3130082OLY2026-10-22
00190776436834Millennium1-1211272026-10-22
00190776436841Millennium63-AOCOMES2026-10-22
00190776436858Millennium100-S03420NSR2026-10-22
00190776436865Millennium1-5255722026-10-22
00190776436872Millennium1-2952026-10-22
00190776436889Millennium1-5053282026-10-22
00190776436896Millennium1-5165062026-10-22
00190776423070Millennium72-4712050SE2026-10-21
00190776435615Millennium72-B9920FADSW2026-10-21
00190776435622Millennium72-B9910FADSW2026-10-21
00190776435639Millennium1-5109332026-10-21
00190776435646Millennium1-5054322026-10-21
00190776435653Millennium72-3295803E2026-10-21
00190776435660Millennium72-1832032026-10-21
00190776435677Millennium72-5225549I2026-10-21
00190776435684Millennium72-31300422026-10-21
00190776435691Millennium1-6158INS2026-10-21
00190776435707Millennium63-5046912026-10-21
00190776435714Millennium63-G120312026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995295530V. MuellerSTERIS Deutschland GmbHFHB2026-09-25
20193489104858MedlineMEDLINE INDUSTRIES, INC.FHB2024-04-25
30193489104855MedlineMEDLINE INDUSTRIES, INC.FHB2024-04-25
G586UR6105490Novo SurgicalNOVO SURGICAL, INC.FHB2023-12-18
G586UR96105400Novo SurgicalNOVO SURGICAL, INC.FHB2023-12-18
G586UR96105490Novo SurgicalNOVO SURGICAL, INC.FHB2023-12-18
00190776303181MillenniumAvalign Technologies, Inc.FHB2023-11-16
00842331159404Novo Surgical Inc. NOVO SURGICAL, INC.FHB2022-11-13
00192896075344PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-20
00192896020245PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-14
00192896020252PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-14
00192896020269PRATT CRYPT HOOKSONTEC INSTRUMENTS, INC.FHB2018-09-14
10885403050183V. MuellerSTERIS CORPORATIONFHB2018-08-30