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
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
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
00840319742914Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742921Hayden MedicalHayden Medical, Inc.KBS2023-03-14
00840319742938Hayden MedicalHayden Medical, Inc.KBS2023-03-14