FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS4417A1
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS4417A
Catalog number
AMS4417A
Device description
ENT PACK
Published
2023-07-17
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
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
B098AMS4417A1PackageHIBCC3In Commercial Distribution
B098AMS4417A0PrimaryHIBCC0

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18006377056CUSTOMESERVICE@ALIGNEDMEDICALSOLUTIONS.COM
18006377056CUSTOMERSERVICE@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
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
B098AMS16554C0Aligned Medical SolutionsAMS16554CAMS16554C2026-04-30
B098AMS165810Aligned Medical SolutionsAMS16581AMS165812026-04-30
B098AMS16643C0Aligned Medical SolutionsAMS16643CAMS16643C2026-04-30

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