FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS17108C0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS17108C
Catalog number
AMS17108C
Device description
Extremity Pack
Published
2026-08-23
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
B098AMS17108C1PackageHIBCC5In Commercial Distribution
B098AMS17108C0PrimaryHIBCC0

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
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
B098AMS169560Aligned Medical SolutionsAMS16956AMS169562026-08-25
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
B098AMS18377A0Aligned Medical SolutionsAMS18377AAMS18377A2026-08-16
B098AMS188840Aligned Medical SolutionsAMS18884AMS188842026-08-16
B098AMS190240Aligned Medical SolutionsAMS19024AMS190242026-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956504554CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956512023CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956517363CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956519299CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956530713CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956536784CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956538801CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956539594CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956541184CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956542723CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956543959CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956544161CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956544857CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956545663CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956545731CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956546615CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956548688CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956548947CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956550537CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956551671CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956552050CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956554221CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956556584CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956557536CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956558113CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956559981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26