FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS11396C0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS11396C
Catalog number
AMS11396C
Device description
OBL Pack
Published
2026-11-03
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
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS11396C1PackageHIBCC6In Commercial Distribution
B098AMS11396C0PrimaryHIBCC0

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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B098AMS126380Aligned Medical SolutionsAMS12638AMS126382026-11-03
B098AMS194900Aligned Medical SolutionsAMS19490AMS194902026-10-02
B098AMS195080Aligned Medical SolutionsAMS19508AMS195082026-11-04
B098AMS197430Aligned Medical SolutionsAMS19743AMS197432026-10-02
B098AMS202680Aligned Medical SolutionsAMS20268AMS202682026-11-03
B098AMS16175B0Aligned Medical SolutionsAMS16175BAMS16175B2026-10-26
B098AMS194890Aligned Medical SolutionsAMS19489AMS194892026-09-29
B098AMS14230A0Aligned Medical SolutionsAMS14230AAMS14230A2026-11-02
B098AMS15987A0Aligned Medical SolutionsAMS15987AAMS15987A2026-11-02
B098AMS18754A0Aligned Medical SolutionsAMS18754AAMS18754A2026-11-02
B098AMS18911A0Aligned Medical SolutionsAMS18911AAMS18911A2026-11-02
B098AMS19657A0Aligned Medical SolutionsAMS19657AAMS19657A2026-11-02
B098AMS198930Aligned Medical SolutionsAMS19893AMS198932026-11-02
B098AMS199380Aligned Medical SolutionsAMS19938AMS199382026-10-02
B098AMS199620Aligned Medical SolutionsAMS19962AMS199622026-10-23
B098AMS13351C0Aligned Medical SolutionsAMS13351CAMS13351C2026-10-16
B098AMS14091A0Aligned Medical SolutionsAMS14091AAMS14091A2026-10-30
B098AMS16554E0Aligned Medical SolutionsAMS16554EAMS16554E2026-10-30
B098AMS17150C0Aligned Medical SolutionsAMS17150CAMS17150C2026-10-31
B098AMS196630Aligned Medical SolutionsAMS19663AMS196632026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160394471MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-11-04
10809160543689HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-11-04
10809160543696HalyardAVID MEDICAL, INC.LRO2026-11-04
10809160543702HalyardAVID MEDICAL, INC.LRO2026-11-04
10809160543764HALYARDMEDICAL ACTION INDUSTRIES INC.LRO2026-11-04
10885632543418SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-11-04
10885632543456SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-11-04
B098AMS195080Aligned Medical SolutionsAligned Medical SolutionsLRO2026-11-04
10198956548800CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956559851CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956582019CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956614406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956616455CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956618671CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956619494CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956619685CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956624474CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10198956625976CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-03
10809160542972HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160542989HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160542996HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543009HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543016HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543030HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543047HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543054HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543061HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543085HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543092HalyardAVID MEDICAL, INC.LRO2026-11-03
10809160543108HalyardAVID MEDICAL, INC.LRO2026-11-03