FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS16554D0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS16554D
Catalog number
AMS16554D
Device description
Face Pack
Published
2026-09-13
Public version status
Update
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
B098AMS16554D1PackageHIBCC6In Commercial Distribution
B098AMS16554D0PrimaryHIBCC0

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B098AMS16068A0Aligned Medical SolutionsAMS16068AAMS16068A2026-10-12
B098AMS188470Aligned Medical SolutionsAMS18847AMS188472026-10-12
B098AMS188480Aligned Medical SolutionsAMS18848AMS188482026-10-12
B098AMS188490Aligned Medical SolutionsAMS18849AMS188492026-10-12
B098AMS188500Aligned Medical SolutionsAMS18850AMS188502026-10-12
B098AMS188510Aligned Medical SolutionsAMS18851AMS188512026-10-12
B098AMS188520Aligned Medical SolutionsAMS18852AMS188522026-10-12
B098AMS195550Aligned Medical SolutionsAMS19555AMS195552026-10-12
B098AMS197330Aligned Medical SolutionsAMS19733AMS197332026-10-12
B098AMS198150Aligned Medical SolutionsAMS19815AMS198152026-09-11
B098AMS199930Aligned Medical SolutionsAMS19993AMS199932026-09-26
B098AMS197680Aligned Medical SolutionsAMS19768AMS197682026-09-18
B098AMS12158A0Aligned Medical SolutionsAMS12158AAMS12158A2026-10-11
B098AMS12324E0Aligned Medical SolutionsAMS12324EAMS12324E2026-10-10
B098AMS12325F0Aligned Medical SolutionsAMS12325FAMS12325F2026-10-10
B098AMS15134C0Aligned Medical SolutionsAMS15134CAMS15134C2026-10-10
B098AMS15967C0Aligned Medical SolutionsAMS15967CAMS15967C2026-10-09
B098AMS18164A0Aligned Medical SolutionsAMS18164AAMS18164A2026-10-09
B098AMS18228A0Aligned Medical SolutionsAMS18228AAMS18228A2026-10-10
B098AMS18454A0Aligned Medical SolutionsAMS18454AAMS18454A2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956542716CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
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10198956554689CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
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10198956568662CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
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10198956570931CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956572195CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956572706CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956580435CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956581128CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956582910CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956584860CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956586772CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12
10198956587250CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-12