FDA.reportPublic FDA data

Avalign

Primary DI
00190776054274
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM76-2582
Device description
"Jacobson ""Heavy"" Needle Holder"
Published
2021-11-03
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776054274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776054274001907760542741907760542740190776054274

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
08022057015747JOSEPH LAMELAS Atrial Lift SystemCORCYM SRLDWS2026-02-03
08022057015754CUFF Aortic Root Exposure DeviceCORCYM SRLDWS2026-02-03
08022057015853SUTURE BELT Circumferential Suture OrganizerCORCYM SRLDWS2026-02-03
08022057015860TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle ExposureCORCYM SRLDWS2026-02-03
08022057015877JOSEPH LAMELAS Knot PusherCORCYM SRLDWS2026-02-03
G4533324301300PEAK MEDICALPeak Medical Distribution Inc.DWS2024-09-17
G586NS30105710Novo SurgicalNOVO SURGICAL, INC.DWS2024-02-22
G586NSCV511010Novo SurgicalNOVO SURGICAL, INC.DWS2024-02-22
G45352745404BC0PEAK MEDICALPeak Medical Distribution Inc.DWS2024-02-01
07898506818204QuinelatoSchobell Industrial LtdaDWS2023-01-12
07898506818211QuinelatoSchobell Industrial LtdaDWS2023-01-12
07898506818198QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506818228QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506853106QuinelatoSchobell Industrial LtdaDWS2023-01-09
07898506853113QuinelatoSchobell Industrial LtdaDWS2023-01-09
07899798203846QuinelatoSchobell Industrial LtdaDWS2022-12-16
ESOT001241NAS & T AGDWS2022-09-15
ESOT001251NAS & T AGDWS2022-09-15
ESOT002331NAS & T AGDWS2022-09-15
ESOT002481NAS & T AGDWS2022-09-15
ESOT002491NAS & T AGDWS2022-09-15
ESOT002501NAS & T AGDWS2022-09-15
ESOT002751NAS & T AGDWS2022-09-15
ESOT002761NAS & T AGDWS2022-09-15
ESOT003241NAS & T AGDWS2022-09-15
ESOT005011NAS & T AGDWS2022-09-15
ESOT005431NAS & T AGDWS2022-09-15
ESOT005741NAS & T AGDWS2022-09-15
ESOT005771NAS & T AGDWS2022-09-15
ESOT005881NAS & T AGDWS2022-09-15