FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS151890
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS15189
Catalog number
AMS15189
Device description
CUSTOM SURGICAL PACK
Published
2024-01-25
Public version status
New
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
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS151891PackageHIBCC6In Commercial Distribution
B098AMS151890PrimaryHIBCC0

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 Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
18006377056CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM

Regulatory Flags#

DUNS number
106580145
Device count
1
Premarket exempt
true
Kit
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
B098AMS12155F0Aligned Medical SolutionsAMS12155FAMS12155F2026-04-30
B098AMS12156C0Aligned Medical SolutionsAMS12156CAMS12156C2026-04-30
B098AMS12195D0Aligned Medical SolutionsAMS12195DAMS12195D2026-04-30
B098AMS12842A0Aligned Medical SolutionsAMS12842AAMS12842A2026-04-30
B098AMS13043B0Aligned Medical SolutionsAMS13043BAMS13043B2026-04-30
B098AMS14568B0Aligned Medical SolutionsAMS14568BAMS14568B2026-04-30
B098AMS14991B0Aligned Medical SolutionsAMS14991BAMS14991B2026-04-30
B098AMS15220B0Aligned Medical SolutionsAMS15220BAMS15220B2026-04-30
B098AMS15559C0Aligned Medical SolutionsAMS15559CAMS15559C2026-04-30
B098AMS15773B0Aligned Medical SolutionsAMS15773BAMS15773B2026-04-30
B098AMS15845A0Aligned Medical SolutionsAMS15845AAMS15845A2026-04-30
B098AMS15888B0Aligned Medical SolutionsAMS15888BAMS15888B2026-04-30
B098AMS16237A0Aligned Medical SolutionsAMS16237AAMS16237A2026-04-30
B098AMS16245C0Aligned Medical SolutionsAMS16245CAMS16245C2026-04-30
B098AMS16332A0Aligned Medical SolutionsAMS16332AAMS16332A2026-04-30
B098AMS16552E0Aligned Medical SolutionsAMS16552EAMS16552E2026-04-30
B098AMS16553C0Aligned Medical SolutionsAMS16553CAMS16553C2026-04-30
B098AMS16554C0Aligned Medical SolutionsAMS16554CAMS16554C2026-04-30
B098AMS165810Aligned Medical SolutionsAMS16581AMS165812026-04-30
B098AMS16643C0Aligned Medical SolutionsAMS16643CAMS16643C2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649988948725SPIRECUTSPIRECUT SALRP2026-05-04
G586961003A0Novo SurgicalNOVO SURGICAL, INC.LRP2024-02-22
G429MSS820160Stainless steel bowl small 6CMMEED SKILL SURGICALLRP2023-03-03
G141588222990Carnegie Surgical LLCCarnegie Surgical LLCLRP2023-02-13
07899798205796QuinelatoSchobell Industrial LtdaLRP2022-12-20
10080196055159MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196818778MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196848041MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10080196996681MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10190001934897MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190021MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190076MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190137MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190304MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190342MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190380MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190489MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190564MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191066MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191073MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191080MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191097MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191103MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191141MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191189MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489191240MEDLINEMEDLINE INDUSTRIES, INC.LRP2022-01-01
10193489190199MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190205MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190212MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16
10193489190250MEDLINEMEDLINE INDUSTRIES, INC.LRP2021-12-16