FDA.reportPublic FDA data

Avalign

Primary DI
00190776250744
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM57-6446
Device description
"Saenger Placenta and Ovum Forceps Curved OL 290mm (11 1/2"")"
Published
2023-11-13
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
00190776250744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776250744001907762507441907762507440190776250744

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). 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
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
00190776435004MillenniumAvalign Technologies, Inc.HDA2026-10-14
00190776434069MillenniumAvalign Technologies, Inc.HDA2026-10-09
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
00190776250089AvalignAvalign Technologies, Inc.HDA2023-09-28
00190776296797MILLENNIUMAvalign Technologies, Inc.HDA2023-09-28
00190776371241MILLENNIUMAvalign Technologies, Inc.HDA2023-09-28
00810123206148Adler Instrument CompanyAdler, Inc.HDA2023-08-24
00190776369125MillenniumAvalign Technologies, Inc.HDA2023-04-03