FDA.report

Aligned Medical Solutions

Primary DI
B098AMS73911
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS7391
Catalog number
AMS7391
Device description
ENT Pack
Published
2018-11-13
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

Related Records

Product Codes

CodeName
OGREar, nose, and throat surgical tray

Product Code Classifications

CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B098AMS73911PackageHIBCC10In Commercial Distribution
B098AMS73910PrimaryHIBCC0

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)637-7056customerservice@alignedmedical

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 DIBrandModelCatalogPublished
B098AMS10064A1Aligned Medical SolutionsAMS10064AAMS10064A2026-01-09
B098AMS10819A1Aligned Medical SolutionsAMS10819AAMS10819A2026-01-09
B098AMS11635A1Aligned Medical SolutionsAMS11635AAMS11635A2026-01-09
B098AMS12397C1Aligned Medical SolutionsAMS12397CAMS12397C2026-01-09
B098AMS12913A1Aligned Medical SolutionsAMS12913AAMS12913A2026-01-09
B098AMS13295C1Aligned Medical SolutionsAMS13295CAMS13295C2026-01-09
B098AMS13321E1Aligned Medical SolutionsAMS13321EAMS13321E2026-01-09
B098AMS13405D1Aligned Medical SolutionsAMS13405DAMS13405D2026-01-09
B098AMS13432C1Aligned Medical SolutionsAMS13432CAMS13432C2026-01-09
B098AMS14519B1Aligned Medical SolutionsAMS14519BAMS14519B2026-01-09
B098AMS14927C1Aligned Medical SolutionsAMS14927CAMS14927C2026-01-09
B098AMS15157D1Aligned Medical SolutionsAMS15157DAMS15157D2026-01-09
B098AMS15515D1Aligned Medical SolutionsAMS15515DAMS15515D2026-01-09
B098AMS15768A1Aligned Medical SolutionsAMS15768AAMS15768A2026-01-09
B098AMS15798A1Aligned Medical SolutionsAMS15798AAMS15798A2026-01-09
B098AMS15801B1Aligned Medical SolutionsAMS15801BAMS15801B2026-01-09
B098AMS15853A1Aligned Medical SolutionsAMS15853AAMS15853A2026-01-09
B098AMS16553B1Aligned Medical SolutionsAMS16553BAMS16553B2026-01-09
B098AMS16554B1Aligned Medical SolutionsAMS16554BAMS16554B2026-01-09
B098AMS16643B1Aligned Medical SolutionsAMS16643BAMS16643B2026-01-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956322897CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-24
50198956376784CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-24
50198956397574CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-24
50198956426779CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-24
50198956324709CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956326352CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956327120CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956355109CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956356687CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956361209CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956362824CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956366815CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956371833CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956374513CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956393033CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956394757CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956401318CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956412741CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956415117CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956415674CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956415988CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956419849CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956425642CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-23
50198956276480CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-19
50198956314915CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-19
50198956321012CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-19
50198956343861CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-19
50198956361520CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-19
50198956361889CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-19
50198956383447CARDINAL HEALTHCardinal Health 200, LLCOGR2026-03-19