FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS13683A1
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS13683A
Catalog number
AMS13683A
Device description
SPINAL KIT - RX
Published
2023-07-10
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
OFTSpinal Epidural Anesthesia Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFTSpinal Epidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS13683A1PackageHIBCC20In Commercial Distribution
B098AMS13683A0PrimaryHIBCC0

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18006377056CUSTOMESERVICE@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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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50198956307795CARDINAL HEALTHCardinal Health 200, LLCOFT2025-12-31
20888277722276Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFT2025-12-18
50198956184037CARDINAL HEALTHCardinal Health 200, LLCOFT2025-08-27
40198459449063MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
40198459453657MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-18
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20809160492120Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFT2025-08-14
40198459446062MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459461263MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
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40198459464448MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459464479MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459466244MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459466350MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459466411MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11
40198459467517MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFT2025-08-11