FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776371241
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
85-30029352
Device description
Sopher Ovum Forceps, 12mm jaw
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDAForceps, obstetrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDAForceps, ObstetricalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776371241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776371241001907763712411907763712410190776371241

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical forceps, reusableA scissors-like obstetrical instrument intended specifically to assist the birth of the foetus during difficult vaginal births. It typically is designed with two curved blades are that are introduced separately and then connected to a handle to exert traction on the foetal head or to rotate the foetal head in order to facilitate its passage through the birth canal. It is made of metal. 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
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
00190776419196MillenniumAvalign Technologies, Inc.HDA2026-04-13
00190776416119MillenniumAvalign Technologies, Inc.HDA2026-02-06
00190776409708MillenniumAvalign Technologies, Inc.HDA2025-09-08
00194613119683MSI Precision Specialty InstrumentsMed Saver, Inc.HDA2025-08-01
00190776406271MillenniumAvalign Technologies, Inc.HDA2025-07-21
00850071684261Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684278Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684285Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684292Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00190776387969MillenniumAvalign Technologies, Inc.HDA2024-11-12
00190776387075MillenniumAvalign Technologies, Inc.HDA2024-09-06
00190776384883MillenniumAvalign Technologies, Inc.HDA2024-08-26
00887482030196Symmetry AuvardASPEN SURGICAL PRODUCTS, INC.HDA2024-08-07
00887482043585Symmetry DeLeeASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482043615Symmetry Kielland-LuikartASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078877Symmetry ElliotASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078914Symmetry KiellandASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078976Symmetry BartonASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00840183505509BR Surgical, LLCBR Surgical, LLCHDA2024-07-22
00840183513344BR Surgical, LLCBR Surgical, LLCHDA2024-07-22
00190776127640MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776142698MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776143886MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776250744AvalignAvalign Technologies, Inc.HDA2023-11-13
00190776250089AvalignAvalign Technologies, Inc.HDA2023-09-28
00190776296797MILLENNIUMAvalign Technologies, Inc.HDA2023-09-28
00810123206148Adler Instrument CompanyAdler, Inc.HDA2023-08-24
00190776369125MillenniumAvalign Technologies, Inc.HDA2023-04-03
00840319750346Hayden MedicalHayden Medical, Inc.HDA2023-03-21
00840319750353Hayden MedicalHayden Medical, Inc.HDA2023-03-21