FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS17150A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS17150A
Catalog number
AMS17150A
Device description
Basic Pack
Published
2026-04-30
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
B098AMS17150A1PackageHIBCC10In Commercial Distribution
B098AMS17150A0PrimaryHIBCC0

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@alignedmedicalsolutions.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
B098AMS10930A0Aligned Medical SolutionsAMS10930AAMS10930A2026-07-03
B098AMS16803A0Aligned Medical SolutionsAMS16803AAMS16803A2026-07-03
B098AMS180170Aligned Medical SolutionsAMS18017AMS180172026-07-03
B098AMS193380Aligned Medical SolutionsAMS19338AMS193382026-07-05
B098AMS110340Aligned Medical SolutionsAMS11034AMS110342023-06-12
B098AMS162410Aligned Medical SolutionsAMS16241AMS162412024-10-08
B098AMS177290Aligned Medical SolutionsAMS17729AMS177292026-06-05
B098AMS12155F0Aligned Medical SolutionsAMS12155FAMS12155F2026-04-30
B098AMS12156C0Aligned Medical SolutionsAMS12156CAMS12156C2026-04-30
B098AMS12195D0Aligned Medical SolutionsAMS12195DAMS12195D2026-04-30
B098AMS12842A0Aligned Medical SolutionsAMS12842AAMS12842A2026-04-30
B098AMS13043B0Aligned Medical SolutionsAMS13043BAMS13043B2026-04-30
B098AMS14568B0Aligned Medical SolutionsAMS14568BAMS14568B2026-04-30
B098AMS14991B0Aligned Medical SolutionsAMS14991BAMS14991B2026-04-30
B098AMS15220B0Aligned Medical SolutionsAMS15220BAMS15220B2026-04-30
B098AMS15559C0Aligned Medical SolutionsAMS15559CAMS15559C2026-04-30
B098AMS15773B0Aligned Medical SolutionsAMS15773BAMS15773B2026-04-30
B098AMS15845A0Aligned Medical SolutionsAMS15845AAMS15845A2026-04-30
B098AMS15888B0Aligned Medical SolutionsAMS15888BAMS15888B2026-04-30
B098AMS16237A0Aligned Medical SolutionsAMS16237AAMS16237A2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956261952CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
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10198956427198CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956445864CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956456969CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956473072CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956477209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956487161CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956493773CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956494619CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956497443CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956498440CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956498747CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956499553CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956502765CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504127CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956504820CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956508897CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956509221CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956510081CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956515505CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956524576CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525122CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525351CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525825CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10198956525924CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-06
10809160526156HALYARDAVID MEDICAL, INC.LRO2026-07-06