FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS131930
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS13193
Catalog number
AMS13193
Device description
ASED 15 Kit
Published
2026-07-22
Public version status
New
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
OJKEye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS131931PackageHIBCC25In Commercial Distribution
B098AMS131930PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any 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
B098AMS14577A0Aligned Medical SolutionsAMS14577AAMS14577A2026-07-22
B098AMS15343A0Aligned Medical SolutionsAMS15343AAMS15343A2026-07-22
B098AMS174900Aligned Medical SolutionsAMS17490AMS174902026-07-22
B098AMS17809A0Aligned Medical SolutionsAMS17809AAMS17809A2026-07-22
B098AMS187270Aligned Medical SolutionsAMS18727AMS187272026-07-22
B098AMS187280Aligned Medical SolutionsAMS18728AMS187282026-07-22
B098AMS191180Aligned Medical SolutionsAMS19118AMS191182026-07-22
B098AMS15342A0Aligned Medical SolutionsAMS15342AAMS15342A2026-07-21
B098AMS17800A0Aligned Medical SolutionsAMS17800AAMS17800A2026-07-21
B098AMS191710Aligned Medical SolutionsAMS19171AMS191712026-07-21
B098AMS192910Aligned Medical SolutionsAMS19291AMS192912026-07-21
00850064198676Aligned Medical SolutionsMISX-6F07MISX-6F072026-07-17
00850064198683Aligned Medical SolutionsMISX-7F07MISX-7F072026-07-17
B098AMS11096B0Aligned Medical SolutionsAMS11096BAMS11096B2026-07-19
B098AMS188250Aligned Medical SolutionsAMS18825AMS188252026-07-19
B098AMS192180Aligned Medical SolutionsAMS19218AMS192182026-07-19
B098AMS192900Aligned Medical SolutionsAMS19290AMS192902026-07-19
B098AMS12381C0Aligned Medical SolutionsAMS12381CAMS12381C2026-07-12
B098AMS14885C0Aligned Medical SolutionsAMS14885CAMS14885C2026-07-12
B098AMS17983A0Aligned Medical SolutionsAMS17983AAMS17983A2026-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS14577A0Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-22
10198956363960CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956385535CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956417434CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956418622CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956484986CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956489882CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956498495CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956518513CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956526013CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956529069CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956531222CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956532175CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956532694CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956533820CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
10198956533981CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-20
B098AMS192180Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-19
10198956382930CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956390546CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956516335CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956519626CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956529441CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
10198956530584CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-16
B098AMS193400Aligned Medical SolutionsAligned Medical SolutionsOJK2026-07-12
10198956339132CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956391949CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956394247CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956414532CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956423213CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09
10198956513464CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-09