FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS188840
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS18884
Catalog number
AMS18884
Device description
Nasal 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
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
B098AMS188841PackageHIBCC12In Commercial Distribution
B098AMS188840PrimaryHIBCC0

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 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
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
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
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10198956547445CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956547766CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956552135CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956553224CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956553316CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
B098AMS188850Aligned Medical SolutionsAligned Medical SolutionsOGR2026-08-17
10198956524064CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956531321CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956532885CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956534025CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956534360CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956537859CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956538665CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956540781CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956541238CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956541412CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10198956542464CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-31
10809160527948HALYARDAVID MEDICAL, INC.OGR2026-07-28
10197106944028CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956371811CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956395053CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956464636CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956479975CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956483538CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956498754CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956502734CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956509207CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27