FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS198150
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19815
Catalog number
AMS19815
Device description
Retina 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
OJKEye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJKEye TrayOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS198151PackageHIBCC6In Commercial Distribution
B098AMS198150PrimaryHIBCC0

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
B098AMS16068A0Aligned Medical SolutionsAMS16068AAMS16068A2026-10-12
B098AMS16554D0Aligned Medical SolutionsAMS16554DAMS16554D2026-09-13
B098AMS188470Aligned Medical SolutionsAMS18847AMS188472026-10-12
B098AMS188480Aligned Medical SolutionsAMS18848AMS188482026-10-12
B098AMS188490Aligned Medical SolutionsAMS18849AMS188492026-10-12
B098AMS188500Aligned Medical SolutionsAMS18850AMS188502026-10-12
B098AMS188510Aligned Medical SolutionsAMS18851AMS188512026-10-12
B098AMS188520Aligned Medical SolutionsAMS18852AMS188522026-10-12
B098AMS195550Aligned Medical SolutionsAMS19555AMS195552026-10-12
B098AMS197330Aligned Medical SolutionsAMS19733AMS197332026-10-12
B098AMS199930Aligned Medical SolutionsAMS19993AMS199932026-09-26
B098AMS197680Aligned Medical SolutionsAMS19768AMS197682026-09-18
B098AMS12158A0Aligned Medical SolutionsAMS12158AAMS12158A2026-10-11
B098AMS12324E0Aligned Medical SolutionsAMS12324EAMS12324E2026-10-10
B098AMS12325F0Aligned Medical SolutionsAMS12325FAMS12325F2026-10-10
B098AMS15134C0Aligned Medical SolutionsAMS15134CAMS15134C2026-10-10
B098AMS15967C0Aligned Medical SolutionsAMS15967CAMS15967C2026-10-09
B098AMS18164A0Aligned Medical SolutionsAMS18164AAMS18164A2026-10-09
B098AMS18228A0Aligned Medical SolutionsAMS18228AAMS18228A2026-10-10
B098AMS18454A0Aligned Medical SolutionsAMS18454AAMS18454A2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956421240CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
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10198956567412CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956567634CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956568082CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956573505CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956579736CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956583887CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956586734CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956589032CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956597563CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956604469CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956463530CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956538702CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956561717CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956564541CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956566873CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956589582CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10198956592780CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
10809160539804HalyardAVID MEDICAL, INC.OJK2026-10-05
10198956589117CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-30
10198956595088CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-30
10198956517417CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956541955CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956582330CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956588356CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10198956592674CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-29
10809160539330HALYARDAVID MEDICAL, INC.OJK2026-09-29
10198956538795CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-25