FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS18377A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS18377A
Catalog number
AMS18377A
Device description
Hand Pack
Published
2026-08-16
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
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS18377A1PackageHIBCC4In Commercial Distribution
B098AMS18377A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain 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
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
10198956379084CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956421462CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956454989CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956468399CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956484795CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956505919CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956507678CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956507975CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956509061CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956509108CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956514423CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956519404CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956530003CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956530775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956533783CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956533844CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956538696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956544246CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956545137CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956545595CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956547612CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551732CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551770CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956552814CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956553668CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956553804CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555259CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555471CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555648CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04