FDA.reportPublic FDA data

Millennium

Primary DI
00190776147402
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
16-550262
Device description
"Lucae Ear Hook Tip 2mm OL 146mm (5 3/4"")"
Published
2020-08-24
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
JYLHook, Microsurgical Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776147402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776147402001907761474021907761474020190776147402

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 allow surgical intervention on those tissues. It is not primarily designed for pulling aside tissues for surgical access purposes (i.e., not a 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
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
04054462906680evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906697evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906703evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906710evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906727evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906734evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906765evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906772evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906796evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906826evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907069evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907113evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907274evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907335evonosevonos GmbH & Co. KGJYL2026-08-21
04054462911585evonosevonos GmbH & Co. KGJYL2026-08-19
04054462901524evonosevonos GmbH & Co. KGJYL2026-08-18
04054462901531evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906741evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906758evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906789evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906802evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906925evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906932evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906949evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906956evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906963evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906970evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906987evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906994evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907007evonosevonos GmbH & Co. KGJYL2026-08-18