FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS198710
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19871
Catalog number
AMS19871
Device description
Laparoscopy Pack
Published
2026-10-14
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
B098AMS198710PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. 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
B098AMS1218F0Aligned Medical SolutionsAMS1218FAMS1218F2026-10-14
B098AMS14689D0Aligned Medical SolutionsAMS14689DAMS14689D2026-10-14
B098AMS14856B0Aligned Medical SolutionsAMS14856BAMS14856B2026-10-14
B098AMS16398B0Aligned Medical SolutionsAMS16398BAMS16398B2026-10-14
B098AMS17118A1Aligned Medical SolutionsAMS17118AAMS17118A2026-10-14
B098AMS17481A0Aligned Medical SolutionsAMS17481AAMS17481A2026-10-14
B098AMS194320Aligned Medical SolutionsAMS19432AMS194322026-10-14
B098AMS198700Aligned Medical SolutionsAMS19870AMS198702026-10-14
B098AMS198720Aligned Medical SolutionsAMS19872AMS198722026-10-14
B098AMS199250Aligned Medical SolutionsAMS19925AMS199252026-10-14
B098AMS199830Aligned Medical SolutionsAMS19983AMS199832026-10-14
B098AMS6270H0Aligned Medical SolutionsAMS6270HAMS6270H2026-10-14
B098PSS2139H0Aligned Medical SolutionsPSS2139HPSS2139H2026-10-14
B098AMS16068A0Aligned Medical SolutionsAMS16068AAMS16068A2026-10-12
B098AMS16554D0Aligned Medical SolutionsAMS16554DAMS16554D2026-09-13
B098AMS188470Aligned Medical SolutionsAMS18847AMS188472026-10-12
B098AMS188480Aligned Medical SolutionsAMS18848AMS188482026-10-12
B098AMS188490Aligned Medical SolutionsAMS18849AMS188492026-10-12
B098AMS188500Aligned Medical SolutionsAMS18850AMS188502026-10-12
B098AMS188510Aligned Medical SolutionsAMS18851AMS188512026-10-12

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