FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098DDS1010E0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
DDS1010E
Catalog number
DDS1010E
Device description
Breast Biopsy Tray
Published
2018-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
B098DDS1010E1PackageHIBCC20In Commercial Distribution
B098DDS1010E0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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 Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(888)637-7056customerservice@alignedmedicalsolutions.com

Regulatory Flags#

DUNS number
106580145
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
B098AMS15230A0Aligned Medical SolutionsAMS15230AAMS15230A2026-06-25
B098AMS12664A0Aligned Medical SolutionsAMS12664AAMS12664A2026-06-23
B098AMS193690Aligned Medical SolutionsAMS19369AMS193692026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956387959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956420076CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956425996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956457119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956459878CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462151CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956473478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956475427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956483675CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956485068CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956490956CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
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10198956493902CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956494435CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956494558CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956496996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497375CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497450CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497696CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956497900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09