FDA.reportPublic FDA data

Millennium

Primary DI
00190776374730
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-1705HM
Device description
"Sickle Knife #1, 5mm curved blade, 6 1/2"" OL"
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
JYOKNIFE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYOKnife, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776374730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776374730001907763747301907763747300190776374730

GMDN Terms#

Term, Definition table
TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. 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
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
00757770419135Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
00757770434268Bausch + LombBausch & Lomb IncorporatedJYO2026-05-11
20757770457568Bausch + LombBausch & Lomb IncorporatedJYO2026-04-30
20757770457551Bausch + LombBausch & Lomb IncorporatedJYO2026-04-29
09348811150233INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-04-10
09348811150134INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-03-16
00757770712281Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
00757770714056Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
09348811108906INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811149923INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150141INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150189INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150196INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811111746INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111753INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111760INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111777INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811108869INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811108913INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109040INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109057INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109064INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109071INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109088INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109095INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109170INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811109187INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
09348811149909INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-23
00757770676316Bausch + LombBausch & Lomb IncorporatedJYO2025-11-14
00844505014694SKULL BASEGrace Medical, Inc.JYO2025-09-26