FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS17800A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS17800A
Catalog number
AMS17800A
Device description
GYN Lap Pack
Published
2026-07-21
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
OHDGynecological Laparoscopic Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS17800A1PackageHIBCC3In Commercial Distribution
B098AMS17800A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. 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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B098AMS131930Aligned Medical SolutionsAMS13193AMS131932026-07-22
B098AMS14577A0Aligned Medical SolutionsAMS14577AAMS14577A2026-07-22
B098AMS15343A0Aligned Medical SolutionsAMS15343AAMS15343A2026-07-22
B098AMS174900Aligned Medical SolutionsAMS17490AMS174902026-07-22
B098AMS17809A0Aligned Medical SolutionsAMS17809AAMS17809A2026-07-22
B098AMS187270Aligned Medical SolutionsAMS18727AMS187272026-07-22
B098AMS187280Aligned Medical SolutionsAMS18728AMS187282026-07-22
B098AMS191180Aligned Medical SolutionsAMS19118AMS191182026-07-22
B098AMS15342A0Aligned Medical SolutionsAMS15342AAMS15342A2026-07-21
B098AMS191710Aligned Medical SolutionsAMS19171AMS191712026-07-21
B098AMS192910Aligned Medical SolutionsAMS19291AMS192912026-07-21
00850064198676Aligned Medical SolutionsMISX-6F07MISX-6F072026-07-17
00850064198683Aligned Medical SolutionsMISX-7F07MISX-7F072026-07-17
B098AMS11096B0Aligned Medical SolutionsAMS11096BAMS11096B2026-07-19
B098AMS188250Aligned Medical SolutionsAMS18825AMS188252026-07-19
B098AMS192180Aligned Medical SolutionsAMS19218AMS192182026-07-19
B098AMS192900Aligned Medical SolutionsAMS19290AMS192902026-07-19
B098AMS12381C0Aligned Medical SolutionsAMS12381CAMS12381C2026-07-12
B098AMS14885C0Aligned Medical SolutionsAMS14885CAMS14885C2026-07-12
B098AMS17983A0Aligned Medical SolutionsAMS17983AAMS17983A2026-07-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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