FDA.report

Aligned Medical Solutions

Primary DI
B098AMS74561
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS7456
Catalog number
AMS7456
Device description
Lap Pack
Published
2018-11-13
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

Related Records

Product Codes

CodeName
FDElaparoscopy kit

Product Code Classifications

CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B098AMS74561PackageHIBCC8In Commercial Distribution
B098AMS74560PrimaryHIBCC0

GMDN Terms

TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)637-7056customerservice@alignedmedical

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 DIBrandModelCatalogPublished
B098AMS10064A1Aligned Medical SolutionsAMS10064AAMS10064A2026-01-09
B098AMS10819A1Aligned Medical SolutionsAMS10819AAMS10819A2026-01-09
B098AMS11635A1Aligned Medical SolutionsAMS11635AAMS11635A2026-01-09
B098AMS12397C1Aligned Medical SolutionsAMS12397CAMS12397C2026-01-09
B098AMS12913A1Aligned Medical SolutionsAMS12913AAMS12913A2026-01-09
B098AMS13295C1Aligned Medical SolutionsAMS13295CAMS13295C2026-01-09
B098AMS13321E1Aligned Medical SolutionsAMS13321EAMS13321E2026-01-09
B098AMS13405D1Aligned Medical SolutionsAMS13405DAMS13405D2026-01-09
B098AMS13432C1Aligned Medical SolutionsAMS13432CAMS13432C2026-01-09
B098AMS14519B1Aligned Medical SolutionsAMS14519BAMS14519B2026-01-09
B098AMS14927C1Aligned Medical SolutionsAMS14927CAMS14927C2026-01-09
B098AMS15157D1Aligned Medical SolutionsAMS15157DAMS15157D2026-01-09
B098AMS15515D1Aligned Medical SolutionsAMS15515DAMS15515D2026-01-09
B098AMS15768A1Aligned Medical SolutionsAMS15768AAMS15768A2026-01-09
B098AMS15798A1Aligned Medical SolutionsAMS15798AAMS15798A2026-01-09
B098AMS15801B1Aligned Medical SolutionsAMS15801BAMS15801B2026-01-09
B098AMS15853A1Aligned Medical SolutionsAMS15853AAMS15853A2026-01-09
B098AMS16553B1Aligned Medical SolutionsAMS16553BAMS16553B2026-01-09
B098AMS16554B1Aligned Medical SolutionsAMS16554BAMS16554B2026-01-09
B098AMS16643B1Aligned Medical SolutionsAMS16643BAMS16643B2026-01-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956285987CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-24
50198956316537CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956344547CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956370959CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956379013CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956397390CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956415902CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956422276CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-23
50198956321920CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956325782CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956334043CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956340044CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956340051CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956343311CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956362756CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956365481CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956384475CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-19
50198956256765CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956295610CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956346053CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956352917CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956358131CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956358384CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956388213CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956388466CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956395662CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956402285CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956412574CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956412666CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16
50198956413649CARDINAL HEALTHCardinal Health 200, LLCFDE2026-03-16