FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS17355A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS17355A
Catalog number
AMS17355A
Device description
Lap GYN Tray
Published
2026-10-05
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
B098AMS17355A1PackageHIBCC8In Commercial Distribution
B098AMS17355A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. 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
B098AMS12186B0Aligned Medical SolutionsAMS12186BAMS12186B2026-10-05
B098AMS183880Aligned Medical SolutionsAMS18388AMS183882026-10-05
B098AMS187660Aligned Medical SolutionsAMS18766AMS187662026-10-05
B098AMS188930Aligned Medical SolutionsAMS18893AMS188932026-10-05
B098AMS192280Aligned Medical SolutionsAMS19228AMS192282026-10-05
B098AMS195700Aligned Medical SolutionsAMS19570AMS195702026-09-11
B098AMS197080Aligned Medical SolutionsAMS19708AMS197082026-10-05
B098AMS197450Aligned Medical SolutionsAMS19745AMS197452026-09-18
00850064198751Aligned Medical Solutions19254S19254S2026-09-23
B098AMS188430Aligned Medical SolutionsAMS18843AMS188432026-09-29
B098AMS194890Aligned Medical SolutionsAMS19489AMS194892026-09-29
B098AMS10256D0Aligned Medical SolutionsAMS10256DAMS10256D2026-09-28
B098AMS167320Aligned Medical SolutionsAMS16732AMS167322026-09-08
B098AMS178940Aligned Medical SolutionsAMS17894AMS178942026-09-28
B098AMS184330Aligned Medical SolutionsAMS18433AMS184332026-09-28
B098AMS192330Aligned Medical SolutionsAMS19233AMS192332026-09-28
B098AMS194460Aligned Medical SolutionsAMS19446AMS194462026-09-28
B098AMS197600Aligned Medical SolutionsAMS19760AMS197602026-09-28
B098AMS14766C0Aligned Medical SolutionsAMS14766CAMS14766C2026-09-26
B098AMS186920Aligned Medical SolutionsAMS18692AMS186922026-09-26

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Primary DI, Brand, Company table
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