FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS14766B0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS14766B
Catalog number
AMS14766B
Device description
Endo Spine 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
OJGNeurological Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS14766B1PackageHIBCC2In Commercial Distribution
B098AMS14766B0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical 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
B098AMS10132C0Aligned Medical SolutionsAMS10132CAMS10132C2026-08-03
B098AMS16817B0Aligned Medical SolutionsAMS16817BAMS16817B2026-08-03
B098AMS17579A0Aligned Medical SolutionsAMS17579AAMS17579A2026-08-03
B098AMS178930Aligned Medical SolutionsAMS17893AMS178932026-08-03
B098AMS178970Aligned Medical SolutionsAMS17897AMS178972026-08-03
B098AMS186950Aligned Medical SolutionsAMS18695AMS186952026-08-03
B098AMS188600Aligned Medical SolutionsAMS18860AMS188602026-08-03
B098AMS191170Aligned Medical SolutionsAMS19117AMS191172026-08-03
B098AMS12325E0Aligned Medical SolutionsAMS12325EAMS12325E2026-07-27
B098AMS167810Aligned Medical SolutionsAMS16781AMS167812026-07-27
B098AMS190780Aligned Medical SolutionsAMS19078AMS190782026-07-27
B098AMS9909C0Aligned Medical SolutionsAMS9909CAMS9909C2026-07-27
B098AMS131940Aligned Medical SolutionsAMS13194AMS131942026-07-26
B098AMS131950Aligned Medical SolutionsAMS13195AMS131952026-07-26
B098AMS131960Aligned Medical SolutionsAMS13196AMS131962026-07-25
B098AMS13932C0Aligned Medical SolutionsAMS13932CAMS13932C2026-07-25
B098AMS16019B0Aligned Medical SolutionsAMS16019BAMS16019B2026-07-25
B098AMS17798A0Aligned Medical SolutionsAMS17798AAMS17798A2026-07-26
B098AMS17843A0Aligned Medical SolutionsAMS17843AAMS17843A2026-07-25
B098AMS179150Aligned Medical SolutionsAMS17915AMS179152026-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528396HalyardAVID MEDICAL, INC.OJG2026-08-03
10809160528587HalyardAVID MEDICAL, INC.OJG2026-08-03
10198956327603CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956353961CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956504936CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956506947CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956513570CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956521346CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956524125CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956531130CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956534131CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956534674CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956538672CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956542297CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956542921CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10809160528242HalyardAVID MEDICAL, INC.OJG2026-07-31
10809160528129HalyardAVID MEDICAL, INC.OJG2026-07-30
10809160527887HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160527924HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160527986HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160528013HalyardAVID MEDICAL, INC.OJG2026-07-28
10809160528037HalyardAVID MEDICAL, INC.OJG2026-07-28
10197106927687CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956337404CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956416444CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956479364CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956480698CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956480919CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956494626CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956500075CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27