FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS195970
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19597
Catalog number
AMS19597
Device description
Myringotomy Pack
Published
2026-07-26
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
B098AMS195971PackageHIBCC16In Commercial Distribution
B098AMS195970PrimaryHIBCC0

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
B098AMS131940Aligned Medical SolutionsAMS13194AMS131942026-07-26
B098AMS131950Aligned Medical SolutionsAMS13195AMS131952026-07-26
B098AMS131960Aligned Medical SolutionsAMS13196AMS131962026-07-25
B098AMS13932C0Aligned Medical SolutionsAMS13932CAMS13932C2026-07-25
B098AMS14766B0Aligned Medical SolutionsAMS14766BAMS14766B2026-07-26
B098AMS16019B0Aligned Medical SolutionsAMS16019BAMS16019B2026-07-25
B098AMS17798A0Aligned Medical SolutionsAMS17798AAMS17798A2026-07-26
B098AMS17843A0Aligned Medical SolutionsAMS17843AAMS17843A2026-07-25
B098AMS179150Aligned Medical SolutionsAMS17915AMS179152026-07-26
B098AMS18256A0Aligned Medical SolutionsAMS18256AAMS18256A2026-07-25
B098AMS187260Aligned Medical SolutionsAMS18726AMS187262026-07-25
B098AMS188360Aligned Medical SolutionsAMS18836AMS188362026-07-26
B098AMS189110Aligned Medical SolutionsAMS18911AMS189112026-07-26
B098AMS190180Aligned Medical SolutionsAMS19018AMS190182026-07-26
B098AMS190570Aligned Medical SolutionsAMS19057AMS190572026-07-25
B098AMS190730Aligned Medical SolutionsAMS19073AMS190732026-07-26
B098AMS190920Aligned Medical SolutionsAMS19092AMS190922026-07-26
B098AMS190930Aligned Medical SolutionsAMS19093AMS190932026-07-26
B098AMS193930Aligned Medical SolutionsAMS19393AMS193932026-07-26
B098AMS194550Aligned Medical SolutionsAMS19455AMS194552026-07-26

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Primary DI, Brand, Company table
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