FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS174900
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS17490
Catalog number
AMS17490
Device description
Vascular Vein Pack
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS174901PackageHIBCC6In Commercial Distribution
B098AMS174900PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-800-637-7056customerservice@alignedmedicalsolutions.com

Regulatory Flags#

DUNS number
106580145
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B098AMS131930Aligned Medical SolutionsAMS13193AMS131932026-07-22
B098AMS14577A0Aligned Medical SolutionsAMS14577AAMS14577A2026-07-22
B098AMS15343A0Aligned Medical SolutionsAMS15343AAMS15343A2026-07-22
B098AMS17809A0Aligned Medical SolutionsAMS17809AAMS17809A2026-07-22
B098AMS187270Aligned Medical SolutionsAMS18727AMS187272026-07-22
B098AMS187280Aligned Medical SolutionsAMS18728AMS187282026-07-22
B098AMS191180Aligned Medical SolutionsAMS19118AMS191182026-07-22
B098AMS15342A0Aligned Medical SolutionsAMS15342AAMS15342A2026-07-21
B098AMS17800A0Aligned Medical SolutionsAMS17800AAMS17800A2026-07-21
B098AMS191710Aligned Medical SolutionsAMS19171AMS191712026-07-21
B098AMS192910Aligned Medical SolutionsAMS19291AMS192912026-07-21
00850064198676Aligned Medical SolutionsMISX-6F07MISX-6F072026-07-17
00850064198683Aligned Medical SolutionsMISX-7F07MISX-7F072026-07-17
B098AMS11096B0Aligned Medical SolutionsAMS11096BAMS11096B2026-07-19
B098AMS188250Aligned Medical SolutionsAMS18825AMS188252026-07-19
B098AMS192180Aligned Medical SolutionsAMS19218AMS192182026-07-19
B098AMS192900Aligned Medical SolutionsAMS19290AMS192902026-07-19
B098AMS12381C0Aligned Medical SolutionsAMS12381CAMS12381C2026-07-12
B098AMS14885C0Aligned Medical SolutionsAMS14885CAMS14885C2026-07-12
B098AMS17983A0Aligned Medical SolutionsAMS17983AAMS17983A2026-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527726HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527733HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527740HalyardAVID MEDICAL, INC.LRO2026-07-22
B098AMS15343A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS187270Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
10653160394068CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-21
10653160394105MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394150MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394167MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394174MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394266MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394280MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10809160527597HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527627HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527641HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527689HalyardAVID MEDICAL, INC.LRO2026-07-21
10809160527696HalyardAVID MEDICAL, INC.LRO2026-07-21
B098AMS15342A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
B098AMS191710Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
B098AMS192910Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-21
10198956263611CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956333895CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956352261CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956361751CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956372801CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956373938CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956382176CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956387614CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956393677CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20
10198956405356CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-20