FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS15230A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS15230A
Catalog number
AMS15230A
Device description
ClosureFast Procedure Pack CFP
Published
2026-06-25
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
B098AMS15230A1PackageHIBCC6In Commercial Distribution
B098AMS15230A0PrimaryHIBCC0

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
B098AMS10930A0Aligned Medical SolutionsAMS10930AAMS10930A2026-07-03
B098AMS16803A0Aligned Medical SolutionsAMS16803AAMS16803A2026-07-03
B098AMS180170Aligned Medical SolutionsAMS18017AMS180172026-07-03
B098AMS193380Aligned Medical SolutionsAMS19338AMS193382026-07-05
B098AMS1217B0Aligned Medical SolutionsAMS1217BAMS1217B2026-06-26
B098AMS13013C0Aligned Medical SolutionsAMS13013CAMS13013C2026-06-28
B098AMS16398A0Aligned Medical SolutionsAMS16398AAMS16398A2026-06-28
B098AMS16589B0Aligned Medical SolutionsAMS16589BAMS16589B2026-06-28
B098AMS177300Aligned Medical SolutionsAMS17730AMS177302026-06-26
B098AMS179160Aligned Medical SolutionsAMS17916AMS179162026-06-28
B098AMS179170Aligned Medical SolutionsAMS17917AMS179172026-06-28
B098AMS187450Aligned Medical SolutionsAMS18745AMS187452026-06-28
B098AMS188340Aligned Medical SolutionsAMS18834AMS188342026-06-28
B098AMS188350Aligned Medical SolutionsAMS18835AMS188352026-06-28
B098AMS193850Aligned Medical SolutionsAMS19385AMS193852026-06-28
B098AMS11520A0Aligned Medical SolutionsAMS11520AMS11520A2023-06-16
B098AMS4887A0Aligned Medical SolutionsAMS4887AAMS4887A2019-04-08
B098AMS12664A0Aligned Medical SolutionsAMS12664AAMS12664A2026-06-23
B098AMS193690Aligned Medical SolutionsAMS19369AMS193692026-06-23
B098AMS110340Aligned Medical SolutionsAMS11034AMS110342023-06-12

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