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
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
B098AMS188840Aligned Medical SolutionsAMS18884AMS188842026-08-16
B098AMS190240Aligned Medical SolutionsAMS19024AMS190242026-08-16
B098AMS190550Aligned Medical SolutionsAMS19055AMS190552026-08-14
B098AMS191910Aligned Medical SolutionsAMS19191AMS191912026-08-16
B098AMS191990Aligned Medical SolutionsAMS19199AMS191992026-08-14
B098AMS19234A0Aligned Medical SolutionsAMS19234AAMS19234A2026-08-16
B098AMS196180Aligned Medical SolutionsAMS19618AMS196182026-08-16
B098AMS196570Aligned Medical SolutionsAMS19657AMS196572026-08-14
B098AMS196600Aligned Medical SolutionsAMS19660AMS196602026-08-14
B098AMS9246C0Aligned Medical SolutionsAMS9246CAMS9246C2026-08-14
B098AMS10132C0Aligned Medical SolutionsAMS10132CAMS10132C2026-08-03
B098AMS16817B0Aligned Medical SolutionsAMS16817BAMS16817B2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956506046CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956513402CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956521223CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956530140CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956530317CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956530324CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956535626CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956549029CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956554245CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956555198CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956555204CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10198956556737CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-18
10197106959497CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956377691CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956442399CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956442436CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956472945CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956513938CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956517264CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956520844CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956522961CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956534827CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956534841CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956534889CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956539846CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956541665CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956542433CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956545526CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956553613CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17
10198956555969CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-17