FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS4331D0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS4331D
Catalog number
AMS4331D
Device description
General Laparotomy Pack
Published
2026-10-30
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
FDELaparoscopy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS4331D1PackageHIBCC4In Commercial Distribution
B098AMS4331D0PrimaryHIBCC0

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
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
B098AMS198900Aligned Medical SolutionsAMS19890AMS198902026-10-31
B098AMS200760Aligned Medical SolutionsAMS20076AMS200762026-10-30
B098AMS201290Aligned Medical SolutionsAMS20129AMS201292026-10-30
B098AMS202330Aligned Medical SolutionsAMS20233AMS202332026-10-30
B098AMS194040Aligned Medical SolutionsAMS19404AMS194042026-10-23
B098AMS10256D0Aligned Medical SolutionsAMS10256DAMS10256D2026-09-28
B098AMS13148C0Aligned Medical SolutionsAMS13148CAMS13148C2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956503519CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-29
10198956611627CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-29
10198956549524CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-23
10198956575172CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956589940CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956590847CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956599055CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956602700CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956602717CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956603547CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956605633CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956606265CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956608238CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956609624CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956609686CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-19
10198956602861CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-15
B098AMS198710Aligned Medical SolutionsAligned Medical SolutionsFDE2026-10-14
10198956586574CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-12
10198956596764CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-12
10198956597570CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-12
10198956506121CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956599222CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956604896CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
10198956610231CARDINAL HEALTHCardinal Health 200, LLCFDE2026-10-06
B098AMS16041C0Aligned Medical SolutionsAligned Medical SolutionsFDE2026-10-02
10198956594845CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-30
10198956596528CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-30
10198956567597CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956568037CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29
10198956590243CARDINAL HEALTHCardinal Health 200, LLCFDE2026-09-29