FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098PSS1936E0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
PSS1936E
Catalog number
PSS1936E
Device description
evlt Tray
Published
2023-07-31
Public version status
New
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
B098PSS1936E1PackageHIBCC10In Commercial Distribution
B098PSS1936E0PrimaryHIBCC0

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 Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B098AMS197600Aligned Medical SolutionsAMS19760AMS197602026-09-28
B098AMS14766C0Aligned Medical SolutionsAMS14766CAMS14766C2026-09-26
B098AMS186920Aligned Medical SolutionsAMS18692AMS186922026-09-26
B098AMS195170Aligned Medical SolutionsAMS19517AMS195172026-09-26
B098AMS195240Aligned Medical SolutionsAMS19524AMS195242026-09-26
B098AMS196900Aligned Medical SolutionsAMS19690AMS196902026-09-25
B098AMS197760Aligned Medical SolutionsAMS19776AMS197762026-09-16
B098AMS197870Aligned Medical SolutionsAMS19787AMS197872026-09-02
B098AMS199160Aligned Medical SolutionsAMS19916AMS199162026-09-26
B098AMS199340Aligned Medical SolutionsAMS19934AMS199342026-09-26
B098AMS199930Aligned Medical SolutionsAMS19993AMS199932026-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956537385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-01
10809160539507HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539514HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539521HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539538HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539552HalyardAVID MEDICAL, INC.LRO2026-10-01
10198956488564CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956513471CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956519565CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956553989CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956558540CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956559486CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956562684CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956567757CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956567955CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956568273CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956568341CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956570856CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956570870CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956570986CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956581005CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956581159CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956584921CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956585188CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956592520CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956593381CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956593589CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956594241CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956595705CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956598249CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30