FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS191960
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19196
Catalog number
AMS19196
Device description
Custom Surgical Pack
Published
2026-08-31
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
B098AMS191961PackageHIBCC6In Commercial Distribution
B098AMS191960PrimaryHIBCC0

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@alignedmedcialsolutions.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
B098AMS13148C0Aligned Medical SolutionsAMS13148CAMS13148C2026-09-22
B098AMS195690Aligned Medical SolutionsAMS19569AMS195692026-09-21
B098AMS197560Aligned Medical SolutionsAMS19756AMS197562026-09-11
B098AMS198180Aligned Medical SolutionsAMS19818AMS198182026-09-11
B09AMS184330Aligned Medical SolutionsAMS18433AMS184332026-08-31
B098AMS12206A0Aligned Medical SolutionsAMS12206AAMS12206A2026-09-18
B098AMS16321B0Aligned Medical SolutionsAMS16321BAMS16321B2026-09-18
B098AMS17151B0Aligned Medical SolutionsAMS17151BAMS17151B2026-09-18
B098AMS187250Aligned Medical SolutionsAMS18725AMS187252026-09-18
B098AMS189300Aligned Medical SolutionsAMS18930AMS189302026-09-18
B098AMS193700Aligned Medical SolutionsAMS19370AMS193702026-09-18
B098AMS194470Aligned Medical SolutionsAMS19447AMS194472026-09-18
B098AMS195520Aligned Medical SolutionsAMS19552AMS195522026-09-18
B098AMS195590Aligned Medical SolutionsAMS19559AMS195592026-09-18
B098AMS195760Aligned Medical SolutionsAMS19576AMS195762026-09-18
B098AMS196360Aligned Medical SolutionsAMS19636AMS196362026-09-02
B098AMS196370Aligned Medical SolutionsAMS19637AMS196372026-09-18
B098AMS196590Aligned Medical SolutionsAMS19659AMS196592026-09-18
B098AMS197450Aligned Medical SolutionsAMS19745AMS197452026-09-18
B098AMS197460Aligned Medical SolutionsAMS19746AMS197462026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160535523HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-09-24
10885632538902SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-09-24
10198956273979CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956336667CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956373839CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956388338CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956426283CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956481978CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956495470CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956503700CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956521193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956530669CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956532052CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956533905CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956547513CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956549555CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956550476CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956554108CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956555877CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956557024CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956557284CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956558427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956559936CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956561809CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956562059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956564589CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956565074CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956566163CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956568952CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956569683CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22