FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS18016A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS18016A
Catalog number
AMS18016A
Device description
Loop Insertion 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
B098AMS18016A1PackageHIBCC20In Commercial Distribution
B098AMS18016A0PrimaryHIBCC0

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
B098AMS10429D0Aligned Medical SolutionsAMS10429DAMS10429D2026-10-26
B098AMS14372A0Aligned Medical SolutionsAMS14372AAMS14372A2026-10-26
B098AMS16175B0Aligned Medical SolutionsAMS16175BAMS16175B2026-10-26
B098AMS16543A0Aligned Medical SolutionsAMS16543AAMS16543A2026-10-26
B098AMS18045A0Aligned Medical SolutionsAMS18045AAMS18045A2026-10-26
B098AMS188450Aligned Medical SolutionsAMS18845AMS188452026-10-02
B098AMS194910Aligned Medical SolutionsAMS19491AMS194912026-10-26
B098AMS197420Aligned Medical SolutionsAMS19742AMS197422026-10-02
B098AMS200500Aligned Medical SolutionsAMS20050AMS200502026-10-26
B098AMS194050Aligned Medical SolutionsAMS19405AMS194052026-10-23
B098AMS199310Aligned Medical SolutionsAMS19931AMS199312026-10-23
B098AMS192280Aligned Medical SolutionsAMS19228AMS192282026-10-05
B098AMS186920Aligned Medical SolutionsAMS18692AMS186922026-09-26
B098AMS12195E0Aligned Medical SolutionsAMS12195EAMS12195E2026-10-23
B098AMS16041C0Aligned Medical SolutionsAMS16041CAMS16041C2026-10-02
B098AMS16179A0Aligned Medical SolutionsAMS16179AAMS16179A2026-10-23
B098AMS173690Aligned Medical SolutionsAMS17369AMS173692026-10-23
B098AMS188920Aligned Medical SolutionsAMS18892AMS188922026-10-23
B098AMS191190Aligned Medical SolutionsAMS19119AMS191192026-10-23
B098AMS191900Aligned Medical SolutionsAMS19190AMS191902026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956515376CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956577282CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956578869CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956590359CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956592902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956596214CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956603752CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956613256CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616646CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616745CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616776CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956616868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956617612CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956621961CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
10198956626287CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-26
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10809160541586HalyardAVID MEDICAL, INC.LRO2026-10-26
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10809160541647HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541654HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541661HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541678HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541685HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541692HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541708HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541715HalyardAVID MEDICAL, INC.LRO2026-10-26
10809160541760HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-10-26
B098AMS10429D0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-26