FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS12325F0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS12325F
Catalog number
AMS12325F
Device description
Abdominoplasty Pack
Published
2026-10-10
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
B098AMS12325F0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
B098AMS12158A0Aligned Medical SolutionsAMS12158AAMS12158A2026-10-11
B098AMS12324E0Aligned Medical SolutionsAMS12324EAMS12324E2026-10-10
B098AMS15134C0Aligned Medical SolutionsAMS15134CAMS15134C2026-10-10
B098AMS15967C0Aligned Medical SolutionsAMS15967CAMS15967C2026-10-09
B098AMS18164A0Aligned Medical SolutionsAMS18164AAMS18164A2026-10-09
B098AMS18228A0Aligned Medical SolutionsAMS18228AAMS18228A2026-10-10
B098AMS18454A0Aligned Medical SolutionsAMS18454AAMS18454A2026-10-09
B098AMS189410Aligned Medical SolutionsAMS18941AMS189412026-10-09
B098AMS189420Aligned Medical SolutionsAMS18942AMS189422026-10-09
B098AMS195280Aligned Medical SolutionsAMS19528AMS195282026-10-02
B098AMS195730Aligned Medical SolutionsAMS19573AMS195732026-09-11
B098AMS196710Aligned Medical SolutionsAMS19671AMS196712026-10-09
B098AMS197230Aligned Medical SolutionsAMS19723AMS197232026-10-04
B098AMS7496B0Aligned Medical SolutionsAMS7496BAMS7496B2026-10-09
B098AMS199160Aligned Medical SolutionsAMS19916AMS199162026-09-26
B098AMS199340Aligned Medical SolutionsAMS19934AMS199342026-09-26
B098AMS195760Aligned Medical SolutionsAMS19576AMS195762026-09-18
B098AMS197600Aligned Medical SolutionsAMS19760AMS197602026-09-28
B098AMS197480Aligned Medical SolutionsAMS19748AMS197482026-09-18
B098AMS12186B0Aligned Medical SolutionsAMS12186BAMS12186B2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS12158A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-11
B098AMS12324E0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-10
B098AMS15134C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-10
B098AMS18228A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-10
10809160540428HalyardAVID MEDICAL, INC.LRO2026-10-09
10809160540435HalyardAVID MEDICAL, INC.LRO2026-10-09
10809160540442HalyardAVID MEDICAL, INC.LRO2026-10-09
10809160540466HalyardAVID MEDICAL, INC.LRO2026-10-09
B098AMS15967C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS18164A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS18454A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS189410Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS189420Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS196710Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
B098AMS7496B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-10-09
10653160394273MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-08
10653160394709MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-08
10809160540091HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540114HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540138HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540152HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540169HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540206HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540213HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540220HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540237HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540244HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540251HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540275HalyardAVID MEDICAL, INC.LRO2026-10-08
10809160540282HalyardAVID MEDICAL, INC.LRO2026-10-08