FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS195290
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19529
Catalog number
AMS19529
Device description
Breast Pack
Published
2026-10-02
Public version status
Update
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
B098AMS195291PackageHIBCC6In Commercial Distribution
B098AMS195290PrimaryHIBCC0

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
true
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
B098AMS186900Aligned Medical SolutionsAMS18690AMS186902026-10-19
B098AMS188100Aligned Medical SolutionsAMS18810AMS188102026-08-31
B098AMS189300Aligned Medical SolutionsAMS18930AMS189302026-09-18
B098AMS13351C0Aligned Medical SolutionsAMS13351CAMS13351C2026-10-16
B098AMS14994B0Aligned Medical SolutionsAMS14994BAMS14994B2026-10-16
B098AMS15543A0Aligned Medical SolutionsAMS15543AAMS15543A2026-10-16
B098AMS16588B0Aligned Medical SolutionsAMS16588BAMS16588B2026-10-16
B098AMS16589C0Aligned Medical SolutionsAMS16589CAMS16589C2026-10-16
B098AMS16935A0Aligned Medical SolutionsAMS16935AAMS16935A2026-10-16
B098AMS17680A0Aligned Medical SolutionsAMS17680AAMS17680A2026-10-16
B098AMS18304A0Aligned Medical SolutionsAMS18304AAMS18304A2026-10-16
B098AMS197790Aligned Medical SolutionsAMS19779AMS197792026-10-16
B098AMS197520Aligned Medical SolutionsAMS19752AMS197522026-09-18
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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