FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098WAL12021
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
WAL1202
Catalog number
WAL1202
Device description
Cataract Pack
Published
2018-11-14
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
B098WAL12021PackageHIBCC20In Commercial Distribution
B098WAL12020PrimaryHIBCC0

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 Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)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
B098AMS188540Aligned Medical SolutionsAMS18854AMS188542026-09-04
B098AMS191940Aligned Medical SolutionsAMS19194AMS191942026-09-04
B098AMS169560Aligned Medical SolutionsAMS16956AMS169562026-08-25
B098AMS17108C0Aligned Medical SolutionsAMS17108CAMS17108C2026-08-23
B098AMS17526A0Aligned Medical SolutionsAMS17526AAMS17526A2026-08-23
B098AMS185880Aligned Medical SolutionsAMS18588AMS185882026-08-21
B098AMS189100Aligned Medical SolutionsAMS18910AMS189102026-08-21
B098AMS190500Aligned Medical SolutionsAMS19050AMS190502026-08-21
B098AMS190740Aligned Medical SolutionsAMS19074AMS190742026-08-21
B098AMS190750Aligned Medical SolutionsAMS19075AMS190752026-08-21
B098AMS190760Aligned Medical SolutionsAMS19076AMS190762026-08-21
B098AMS192350Aligned Medical SolutionsAMS19235AMS192352026-08-21
B098AMS197320Aligned Medical SolutionsAMS19732AMS197322026-08-19
B098AMS188850Aligned Medical SolutionsAMS18885AMS188852026-08-17
B098AMS191930Aligned Medical SolutionsAMS19193AMS191932026-08-17
B098AMS14529C0Aligned Medical SolutionsAMS14529CAMS14529C2026-08-14
B098AMS14762A0Aligned Medical SolutionsAMS14762AAMS14762A2026-08-16
B098AMS17107C0Aligned Medical SolutionsAMS17107CAMS17107C2026-08-14
B098AMS17337A0Aligned Medical SolutionsAMS17337AAMS17337A2026-08-14
B098AMS17686A0Aligned Medical SolutionsAMS17686AAMS17686A2026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956561236CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956563360CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10198956565135CARDINAL HEALTHCardinal Health 200, LLCOJK2026-08-26
10809160531839HalyardAVID MEDICAL, INC.OJK2026-08-26
B098AMS17526A0Aligned Medical SolutionsAligned Medical SolutionsOJK2026-08-23
10809160530733HalyardAVID MEDICAL, INC.OJK2026-08-19