FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS131960
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS13196
Catalog number
AMS13196
Device description
Dropper Bottles Kit
Published
2026-07-25
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
B098AMS131961PackageHIBCC20In Commercial Distribution
B098AMS131960PrimaryHIBCC0

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
B098AMS10132C0Aligned Medical SolutionsAMS10132CAMS10132C2026-08-03
B098AMS16817B0Aligned Medical SolutionsAMS16817BAMS16817B2026-08-03
B098AMS17579A0Aligned Medical SolutionsAMS17579AAMS17579A2026-08-03
B098AMS178930Aligned Medical SolutionsAMS17893AMS178932026-08-03
B098AMS178970Aligned Medical SolutionsAMS17897AMS178972026-08-03
B098AMS186950Aligned Medical SolutionsAMS18695AMS186952026-08-03
B098AMS188600Aligned Medical SolutionsAMS18860AMS188602026-08-03
B098AMS191170Aligned Medical SolutionsAMS19117AMS191172026-08-03
B098AMS12325E0Aligned Medical SolutionsAMS12325EAMS12325E2026-07-27
B098AMS167810Aligned Medical SolutionsAMS16781AMS167812026-07-27
B098AMS190780Aligned Medical SolutionsAMS19078AMS190782026-07-27
B098AMS9909C0Aligned Medical SolutionsAMS9909CAMS9909C2026-07-27
B098AMS131940Aligned Medical SolutionsAMS13194AMS131942026-07-26
B098AMS131950Aligned Medical SolutionsAMS13195AMS131952026-07-26
B098AMS13932C0Aligned Medical SolutionsAMS13932CAMS13932C2026-07-25
B098AMS14766B0Aligned Medical SolutionsAMS14766BAMS14766B2026-07-26
B098AMS16019B0Aligned Medical SolutionsAMS16019BAMS16019B2026-07-25
B098AMS17798A0Aligned Medical SolutionsAMS17798AAMS17798A2026-07-26
B098AMS17843A0Aligned Medical SolutionsAMS17843AAMS17843A2026-07-25
B098AMS179150Aligned Medical SolutionsAMS17915AMS179152026-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956414884CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956416222CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
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10198956534230CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956536661CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956538016CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956538771CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956540750CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956540798CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10198956544567CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-31
10809160528228HalyardAVID MEDICAL, INC.OJK2026-07-31
10809160528235HalyardAVID MEDICAL, INC.OJK2026-07-31
10809160528143HalyardAVID MEDICAL, INC.OJK2026-07-30
10809160528082HalyardAVID MEDICAL, INC.OJK2026-07-29
10809160528105HalyardAVID MEDICAL, INC.OJK2026-07-29
10198956409712CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956414471CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956414501CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956470538CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956480490CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956520431CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956523722CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956528581CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956528628CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956529199CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956531994CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956533363CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956533448CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534117CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27
10198956534124CARDINAL HEALTHCardinal Health 200, LLCOJK2026-07-27