FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS95700
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS9570
Catalog number
AMS9570
Device description
Abdominoplasty Pack
Published
2019-06-18
Public version status
Update
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
B098AMS95700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)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
Contains natural rubber latex
true

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
B098AMS197450Aligned Medical SolutionsAMS19745AMS197452026-09-18
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

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