FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS12195E0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS12195E
Catalog number
AMS12195E
Device description
Neuro Pack
Published
2026-10-23
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
B098AMS12195E0PrimaryHIBCC0

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
true
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
B098AMS16041C0Aligned Medical SolutionsAMS16041CAMS16041C2026-10-02
B098AMS16179A0Aligned Medical SolutionsAMS16179AAMS16179A2026-10-23
B098AMS173690Aligned Medical SolutionsAMS17369AMS173692026-10-23
B098AMS188920Aligned Medical SolutionsAMS18892AMS188922026-10-23
B098AMS191190Aligned Medical SolutionsAMS19119AMS191192026-10-23
B098AMS191900Aligned Medical SolutionsAMS19190AMS191902026-10-23
B098AMS19291A0Aligned Medical SolutionsAMS19291AAMS19291A2026-10-23
B098AMS194040Aligned Medical SolutionsAMS19404AMS194042026-10-23
B098AMS194050Aligned Medical SolutionsAMS19405AMS194052026-10-23
B098AMS197690Aligned Medical SolutionsAMS19769AMS197692026-10-23
B098AMS199310Aligned Medical SolutionsAMS19931AMS199312026-10-23
B098AMS199320Aligned Medical SolutionsAMS19932AMS199322026-10-23
B098AMS199620Aligned Medical SolutionsAMS19962AMS199622026-10-23
B098AMS199880Aligned Medical SolutionsAMS19988AMS199882026-10-23
B098AMS199890Aligned Medical SolutionsAMS19989AMS199892026-10-23
B098AMS201510Aligned Medical SolutionsAMS20151AMS201512026-10-23
B098AMS186900Aligned Medical SolutionsAMS18690AMS186902026-10-19
B098AMS188100Aligned Medical SolutionsAMS18810AMS188102026-08-31
B098AMS195290Aligned Medical SolutionsAMS19529AMS195292026-10-02
B098AMS189300Aligned Medical SolutionsAMS18930AMS189302026-09-18

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