FDA.reportPublic FDA data

Avalign

Primary DI
00190776250737
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM57-6401
Device description
IUD Removal Hook
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
HHFREMOVER, INTRAUTERINE DEVICE, CONTRACEPTIVE, HOOK-TYPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHFRemover, Intrauterine Device, Contraceptive, Hook-TypeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776250737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776250737001907762507371907762507370190776250737

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord scissors, reusableA hand-held manual surgical instrument designed specifically to cut the umbilical cord after birth. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is metallic and is available in various designs and sizes; the blades can have a variety of sizes and designs, e.g., curved, acutely angled at the tip, or have flat opposing moon shapes, and may be serrated. 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
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423988MillenniumAvalign Technologies, Inc.HHF2026-08-27
B382SD915598220Surgical DirectSurgical Direct, Inc.HHF2026-07-28
B382SD915599320Surgical DirectSurgical Direct, Inc.HHF2026-07-28
05010058078482InstrapacROBINSON HEALTHCARE LIMITEDHHF2025-05-21
05010058178489InstrapacROBINSON HEALTHCARE LIMITEDHHF2025-05-21
00194613032456MSI Precision Specialty InstrumentsMed Saver, Inc.HHF2025-03-21
00887482040751Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HHF2024-09-05
00840183500092BR Surgical, LLCBR Surgical, LLCHHF2024-02-29
00840183500870BR Surgical, LLCBR Surgical, LLCHHF2024-02-29
00840183502263BR Surgical, LLCBR Surgical, LLCHHF2024-02-29
GYNX292001GynexGYNEX CORPORATIONHHF2023-12-26
GYNX293001GynexGYNEX CORPORATIONHHF2023-12-26
GYNX298501GynexGYNEX CORPORATIONHHF2023-12-26
GYNX291000GynexGYNEX CORPORATIONHHF2023-12-26
GYNX292000GynexGYNEX CORPORATIONHHF2023-12-26
GYNX293500GynexGYNEX CORPORATIONHHF2023-12-26
GYNX295500GynexGYNEX CORPORATIONHHF2023-12-26
GYNX298000GynexGYNEX CORPORATIONHHF2023-12-26
GYNX298500GynexGYNEX CORPORATIONHHF2023-12-26
GYNX299000GynexGYNEX CORPORATIONHHF2023-12-26
G586OB96417600Novo SurgicalNOVO SURGICAL, INC.HHF2023-12-18
G586OB96417670Novo SurgicalNOVO SURGICAL, INC.HHF2023-12-18
G586OB96417680Novo SurgicalNOVO SURGICAL, INC.HHF2023-12-18
GYNX290100GynexGYNEX CORPORATIONHHF2023-12-13
GYNX290200GynexGYNEX CORPORATIONHHF2023-12-13
05010058070240InstrapacROBINSON HEALTHCARE LIMITEDHHF2023-08-08
05010058170247InstrapacROBINSON HEALTHCARE LIMITEDHHF2023-08-08
00842962162101HNM MEDICALHNM STAINLESS, LLC.HHF2023-05-27
00842962162118HNM MEDICALHNM STAINLESS, LLC.HHF2023-05-27
00842962129036HNM MEDICALHNM STAINLESS, LLC.HHF2023-03-30