FDA.reportPublic FDA data

Millennium

Primary DI
00190776327132
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
2-6161
Device description
Meltzer Adenoid Punch, #1
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
KBSPUNCH, ADENOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBSPunch, AdenoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776327132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776327132001907763271321907763271320190776327132

GMDN Terms#

Term, Definition table
TermDefinition
Adenoid curette, reusableA hand-held manual surgical instrument designed for cutting and excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge that is used to facilitate the removal of the tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the adenoids. 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
00190776435479Millennium1-510489L2026-10-20
00190776435486Millennium1-FK177R2026-10-20
00190776435493Millennium72-5255006452026-10-20
00190776435509Millennium1-3910152026-10-20
00190776435516Millennium1-750750202026-10-20
00190776435523Millennium1-750750402026-10-20
00190776435530Millennium1-636012026-10-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397029MillenniumAvalign Technologies, Inc.KBS2026-07-22
00190776403393MillenniumAvalign Technologies, Inc.KBS2026-07-21
00190776400446MillenniumAvalign Technologies, Inc.KBS2026-07-17
00757770508709Bausch + LombBausch & Lomb IncorporatedKBS2026-04-30
00757770508723Bausch + LombBausch & Lomb IncorporatedKBS2026-04-30
00757770508693Bausch + LombBausch & Lomb IncorporatedKBS2025-08-07
00757770508716Bausch + LombBausch & Lomb IncorporatedKBS2025-08-07
04049197474801RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKBS2024-09-20
04049197474818RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKBS2024-09-20
00840183509415BR Surgical, LLCBR Surgical, LLCKBS2024-06-03
00840183512408BR Surgical, LLCBR Surgical, LLCKBS2024-06-03
00842331195471Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
G586E8251130Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
G586E8251140Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
G586E8261110Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
G586E8261120Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
G586E8263310Novo SurgicalNOVO SURGICAL, INC.KBS2023-12-18
00842331194412Novo Surgical Inc. NOVO SURGICAL, INC.KBS2023-12-07
00842331194429Novo Surgical Inc. NOVO SURGICAL, INC.KBS2023-12-07
00190776049416AvalignAvalign Technologies, Inc.KBS2023-09-28
00842962149591HNM MEDICALHNM STAINLESS, LLC.KBS2023-04-06
00842962149607HNM MEDICALHNM STAINLESS, LLC.KBS2023-04-06
00842962149614HNM MEDICALHNM STAINLESS, LLC.KBS2023-04-06
00840319742846Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742853Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742860Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742877Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742884Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742891Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742907Hayden MedicalHayden Medical, Inc.KBS2023-03-14