FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS189300
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS18930
Catalog number
AMS18930
Device description
Cataract Pack
Published
2026-09-18
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
B098AMS189301PackageHIBCC8In Commercial Distribution
B098AMS189300PrimaryHIBCC0

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
true
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
B098AMS186900Aligned Medical SolutionsAMS18690AMS186902026-10-19
B098AMS188100Aligned Medical SolutionsAMS18810AMS188102026-08-31
B098AMS195290Aligned Medical SolutionsAMS19529AMS195292026-10-02
B098AMS13351C0Aligned Medical SolutionsAMS13351CAMS13351C2026-10-16
B098AMS14994B0Aligned Medical SolutionsAMS14994BAMS14994B2026-10-16
B098AMS15543A0Aligned Medical SolutionsAMS15543AAMS15543A2026-10-16
B098AMS16588B0Aligned Medical SolutionsAMS16588BAMS16588B2026-10-16
B098AMS16589C0Aligned Medical SolutionsAMS16589CAMS16589C2026-10-16
B098AMS16935A0Aligned Medical SolutionsAMS16935AAMS16935A2026-10-16
B098AMS17680A0Aligned Medical SolutionsAMS17680AAMS17680A2026-10-16
B098AMS18304A0Aligned Medical SolutionsAMS18304AAMS18304A2026-10-16
B098AMS197790Aligned Medical SolutionsAMS19779AMS197792026-10-16
B098AMS197520Aligned Medical SolutionsAMS19752AMS197522026-09-18
B098AMS1218F0Aligned Medical SolutionsAMS1218FAMS1218F2026-10-14
B098AMS14689D0Aligned Medical SolutionsAMS14689DAMS14689D2026-10-14
B098AMS14856B0Aligned Medical SolutionsAMS14856BAMS14856B2026-10-14
B098AMS16398B0Aligned Medical SolutionsAMS16398BAMS16398B2026-10-14
B098AMS17118A1Aligned Medical SolutionsAMS17118AAMS17118A2026-10-14
B098AMS17481A0Aligned Medical SolutionsAMS17481AAMS17481A2026-10-14
B098AMS194320Aligned Medical SolutionsAMS19432AMS194322026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956613195CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-19
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10198956564237CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-13
10198956421240CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956553361CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956562912CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
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
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10198956583887CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
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10198956597563CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
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10198956538702CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06
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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