FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS196590
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19659
Catalog number
AMS19659
Device description
Cataract Pack
Published
2026-09-18
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
B098AMS196591PackageHIBCC12In Commercial Distribution
B098AMS196590PrimaryHIBCC0

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
B098AMS12206A0Aligned Medical SolutionsAMS12206AAMS12206A2026-09-18
B098AMS16321B0Aligned Medical SolutionsAMS16321BAMS16321B2026-09-18
B098AMS17151B0Aligned Medical SolutionsAMS17151BAMS17151B2026-09-18
B098AMS187250Aligned Medical SolutionsAMS18725AMS187252026-09-18
B098AMS189300Aligned Medical SolutionsAMS18930AMS189302026-09-18
B098AMS193700Aligned Medical SolutionsAMS19370AMS193702026-09-18
B098AMS194470Aligned Medical SolutionsAMS19447AMS194472026-09-18
B098AMS195520Aligned Medical SolutionsAMS19552AMS195522026-09-18
B098AMS195590Aligned Medical SolutionsAMS19559AMS195592026-09-18
B098AMS195760Aligned Medical SolutionsAMS19576AMS195762026-09-18
B098AMS196360Aligned Medical SolutionsAMS19636AMS196362026-09-02
B098AMS196370Aligned Medical SolutionsAMS19637AMS196372026-09-18
B098AMS197450Aligned Medical SolutionsAMS19745AMS197452026-09-18
B098AMS197460Aligned Medical SolutionsAMS19746AMS197462026-09-18
B098AMS197470Aligned Medical SolutionsAMS19747AMS197472026-09-18
B098AMS197480Aligned Medical SolutionsAMS19748AMS197482026-09-18
B098AMS197520Aligned Medical SolutionsAMS19752AMS197522026-09-18
B098AMS197680Aligned Medical SolutionsAMS19768AMS197682026-09-18
B098AMS198620Aligned Medical SolutionsAMS19862AMS198622026-08-31
B098AMS7712B0Aligned Medical SolutionsAMS7712BAMS7712B2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538012HalyardAVID MEDICAL, INC.OJK2026-09-20
10809160537657HalyardAVID MEDICAL, INC.OJK2026-09-19
10809160537718HalyardAVID MEDICAL, INC.OJK2026-09-19
10809160536919HalyardAVID MEDICAL, INC.OJK2026-09-18
10809160536926HalyardAVID MEDICAL, INC.OJK2026-09-18
B098AMS189300Aligned Medical SolutionsAligned Medical SolutionsOJK2026-09-18
10198956561489CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956561588CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956562882CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956563124CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956563391CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956563667CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956566897CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956567191CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956568617CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956569096CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956569218CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570368CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570443CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570542CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10198956570832CARDINAL HEALTHCardinal Health 200, LLCOJK2026-09-04
10809160532874HalyardAVID MEDICAL, INC.OJK2026-09-04
10809160532904HalyardAVID MEDICAL, INC.OJK2026-09-04
10809160532959HalyardAVID MEDICAL, INC.OJK2026-09-04
10809160532003HalyardAVID MEDICAL, INC.OJK2026-08-27
10809160532102HalyardAVID MEDICAL, INC.OJK2026-08-27
10198956417533CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956478947CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956503069CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956556539CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26