FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS197450
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19745
Catalog number
AMS19745
Device description
Basin Pack
Published
2026-09-18
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
B098AMS197451PackageHIBCC6In Commercial Distribution
B098AMS197450PrimaryHIBCC0

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
Handling Environment Atmospheric Pressure00

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
B098AMS197600Aligned Medical SolutionsAMS19760AMS197602026-09-28
B098AMS197480Aligned Medical SolutionsAMS19748AMS197482026-09-18
B098AMS12186B0Aligned Medical SolutionsAMS12186BAMS12186B2026-10-05
B098AMS17355A0Aligned Medical SolutionsAMS17355AAMS17355A2026-10-05
B098AMS183880Aligned Medical SolutionsAMS18388AMS183882026-10-05
B098AMS187660Aligned Medical SolutionsAMS18766AMS187662026-10-05
B098AMS188930Aligned Medical SolutionsAMS18893AMS188932026-10-05
B098AMS192280Aligned Medical SolutionsAMS19228AMS192282026-10-05
B098AMS195700Aligned Medical SolutionsAMS19570AMS195702026-09-11
B098AMS197080Aligned Medical SolutionsAMS19708AMS197082026-10-05
00850064198751Aligned Medical Solutions19254S19254S2026-09-23
B098AMS188430Aligned Medical SolutionsAMS18843AMS188432026-09-29
B098AMS194890Aligned Medical SolutionsAMS19489AMS194892026-09-29
B098AMS10256D0Aligned Medical SolutionsAMS10256DAMS10256D2026-09-28
B098AMS167320Aligned Medical SolutionsAMS16732AMS167322026-09-08
B098AMS178940Aligned Medical SolutionsAMS17894AMS178942026-09-28
B098AMS184330Aligned Medical SolutionsAMS18433AMS184332026-09-28
B098AMS192330Aligned Medical SolutionsAMS19233AMS192332026-09-28
B098AMS194460Aligned Medical SolutionsAMS19446AMS194462026-09-28
B098AMS14766C0Aligned Medical SolutionsAMS14766CAMS14766C2026-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160394273MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-08
10653160394709MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-08
10809160540091HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540114HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540138HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540152HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540169HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540206HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540213HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540220HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540237HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540244HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540251HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540275HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540282HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540299HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540312HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540329HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540336HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540343HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540350HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540374HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540381HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540398HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540404HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540411HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540022HalyardAVID MEDICAL, INC.LRO2026-10-07
10809160540046HalyardAVID MEDICAL, INC.LRO2026-10-07
10809160540077HalyardAVID MEDICAL, INC.LRO2026-10-07
10809160540084HalyardAVID MEDICAL, INC.LRO2026-10-07