FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS14065A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS14065A
Catalog number
AMS14065A
Device description
ENT PACK
Published
2024-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGREar, Nose, And Throat Surgical Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS14065A1PackageHIBCC6In Commercial Distribution
B098AMS14065A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8006377056CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM

Regulatory Flags#

DUNS number
106580145
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B098AMS110340Aligned Medical SolutionsAMS11034AMS110342023-06-12
B098AMS162410Aligned Medical SolutionsAMS16241AMS162412024-10-08
B098AMS177290Aligned Medical SolutionsAMS17729AMS177292026-06-05
B098AMS12155F0Aligned Medical SolutionsAMS12155FAMS12155F2026-04-30
B098AMS12156C0Aligned Medical SolutionsAMS12156CAMS12156C2026-04-30
B098AMS12195D0Aligned Medical SolutionsAMS12195DAMS12195D2026-04-30
B098AMS12842A0Aligned Medical SolutionsAMS12842AAMS12842A2026-04-30
B098AMS13043B0Aligned Medical SolutionsAMS13043BAMS13043B2026-04-30
B098AMS14568B0Aligned Medical SolutionsAMS14568BAMS14568B2026-04-30
B098AMS14991B0Aligned Medical SolutionsAMS14991BAMS14991B2026-04-30
B098AMS15220B0Aligned Medical SolutionsAMS15220BAMS15220B2026-04-30
B098AMS15559C0Aligned Medical SolutionsAMS15559CAMS15559C2026-04-30
B098AMS15773B0Aligned Medical SolutionsAMS15773BAMS15773B2026-04-30
B098AMS15845A0Aligned Medical SolutionsAMS15845AAMS15845A2026-04-30
B098AMS15888B0Aligned Medical SolutionsAMS15888BAMS15888B2026-04-30
B098AMS16237A0Aligned Medical SolutionsAMS16237AAMS16237A2026-04-30
B098AMS16245C0Aligned Medical SolutionsAMS16245CAMS16245C2026-04-30
B098AMS16332A0Aligned Medical SolutionsAMS16332AAMS16332A2026-04-30
B098AMS16552E0Aligned Medical SolutionsAMS16552EAMS16552E2026-04-30
B098AMS16553C0Aligned Medical SolutionsAMS16553CAMS16553C2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956498792CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
10198956500563CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-05
B098AMS177290Aligned Medical SolutionsAligned Medical SolutionsOGR2026-06-05
10198956443570CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956479609CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956490857CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956492653CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956494237CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03
10198956497009CARDINAL HEALTHCardinal Health 200, LLCOGR2026-06-03