FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS188450
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS18845
Catalog number
AMS18845
Device description
LTT Iantrek Pack
Published
2026-10-02
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
B098AMS188451PackageHIBCC10In Commercial Distribution
B098AMS188450PrimaryHIBCC0

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
B098AMS10429D0Aligned Medical SolutionsAMS10429DAMS10429D2026-10-26
B098AMS14372A0Aligned Medical SolutionsAMS14372AAMS14372A2026-10-26
B098AMS16175B0Aligned Medical SolutionsAMS16175BAMS16175B2026-10-26
B098AMS16543A0Aligned Medical SolutionsAMS16543AAMS16543A2026-10-26
B098AMS18016A0Aligned Medical SolutionsAMS18016AAMS18016A2026-09-13
B098AMS18045A0Aligned Medical SolutionsAMS18045AAMS18045A2026-10-26
B098AMS194910Aligned Medical SolutionsAMS19491AMS194912026-10-26
B098AMS197420Aligned Medical SolutionsAMS19742AMS197422026-10-02
B098AMS200500Aligned Medical SolutionsAMS20050AMS200502026-10-26
B098AMS194050Aligned Medical SolutionsAMS19405AMS194052026-10-23
B098AMS199310Aligned Medical SolutionsAMS19931AMS199312026-10-23
B098AMS192280Aligned Medical SolutionsAMS19228AMS192282026-10-05
B098AMS186920Aligned Medical SolutionsAMS18692AMS186922026-09-26
B098AMS12195E0Aligned Medical SolutionsAMS12195EAMS12195E2026-10-23
B098AMS16041C0Aligned Medical SolutionsAMS16041CAMS16041C2026-10-02
B098AMS16179A0Aligned Medical SolutionsAMS16179AAMS16179A2026-10-23
B098AMS173690Aligned Medical SolutionsAMS17369AMS173692026-10-23
B098AMS188920Aligned Medical SolutionsAMS18892AMS188922026-10-23
B098AMS191190Aligned Medical SolutionsAMS19119AMS191192026-10-23
B098AMS191900Aligned Medical SolutionsAMS19190AMS191902026-10-23

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Primary DI, Brand, Company table
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10198956597563CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956604469CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-12
10198956463530CARDINAL HEALTHCardinal Health 200, LLCOJK2026-10-06