FDA.reportPublic FDA data

Millennium

Primary DI
00190776435530
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-63601
Device description
Paparella Pick 6 1/2'', Straight Shaft, Bent Right, 1.0mm Wide x 4.0mm Long Blade, Hexagonal Handle
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYTPick, Microsurgical Ear

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776435530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776435530001907764355301907764355300190776435530

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776435479Millennium1-510489L2026-10-20
00190776435486Millennium1-FK177R2026-10-20
00190776435493Millennium72-5255006452026-10-20
00190776435509Millennium1-3910152026-10-20
00190776435516Millennium1-750750202026-10-20
00190776435523Millennium1-750750402026-10-20
00190776435547Millennium72-5255540SL2026-10-20
00190776435554Millennium1-9356482026-10-20
00190776435561Millennium72-522056116202026-10-20
00190776435578Millennium1-225402L2026-10-20
00190776435585Millennium1-225402R2026-10-20
00190776435592Millennium1-6020222026-10-20
00190776435608Millennium1-6020172026-10-20
00190776436612Millenium85-630049412026-10-20
00190776436629Millenium85-110109462026-10-20
00190776436636Millenium85-520062822026-10-20
00190776436643Millenium85-520029442026-10-20
00190776436674Millenium85-420339012026-10-20
00190776436681Millenium85-520234622026-10-20
00190776436698Millenium85-780692982026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434281MillenniumAvalign Technologies, Inc.JYT2026-10-06
09348811111951INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-07-31
09348811111982INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-07-31
09348811112026INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-07-31
09348811155320INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-07-31
09348811155337INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-07-31
09348811149756INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-07-30
09348811111944INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-06-02
09348811150301INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150318INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150325INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150349INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150363INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150387INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150400INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811150417INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-05-29
09348811111975INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-04-24
09348811022677INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-18
09348811111968INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
09348811112019INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
09348811155344INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-23
09348811109828INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109835INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109842INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811109859INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111913INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111920INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811111937INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
09348811150295INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-11-21
G04365983B0BEARBear-Ent, LLCJYT2024-02-03