FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS195700
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19570
Catalog number
AMS19570
Device description
Knee Arthroscopy Pack
Published
2026-09-11
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
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS195701PackageHIBCC3In Commercial Distribution
B098AMS195700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. 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
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
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
B098AMS197600Aligned Medical SolutionsAMS19760AMS197602026-09-28
B098AMS14766C0Aligned Medical SolutionsAMS14766CAMS14766C2026-09-26
B098AMS186920Aligned Medical SolutionsAMS18692AMS186922026-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956286672CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956301511CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956306059CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956354494CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956379824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956402416CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956439702CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956470163CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956512146CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956514522CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956519985CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956523555CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956532083CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956543089CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956543942CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956545359CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548855CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548916CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548961CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956552012CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956552098CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956554696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956556102CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956556690CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956560796CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956562721CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956567399CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956567696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956568129CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956568747CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06