FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
00850064198232
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
PRO6025
Catalog number
PRO6025
Device description
Drape Femoral Angiography 84 x 159IN W/Pouches
Published
2025-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10850064198239PackageGS18In Commercial Distribution
00850064198232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006419823910850064198239
00850064198232008500641982328500641982320850064198232

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 Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
106580145
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
B098AMS174900Aligned Medical SolutionsAMS17490AMS174902026-07-22
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

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
B098AMS174900Aligned 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
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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