FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS8132B0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS8132B
Catalog number
AMS8132B
Device description
Hysteroscopy Pack
Published
2026-09-18
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
B098AMS8132B1PackageHIBCC6In Commercial Distribution
B098AMS8132B0PrimaryHIBCC0

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
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
B098AMS12206A0Aligned Medical SolutionsAMS12206AAMS12206A2026-09-18
B098AMS16321B0Aligned Medical SolutionsAMS16321BAMS16321B2026-09-18
B098AMS17151B0Aligned Medical SolutionsAMS17151BAMS17151B2026-09-18
B098AMS187250Aligned Medical SolutionsAMS18725AMS187252026-09-18
B098AMS189300Aligned Medical SolutionsAMS18930AMS189302026-09-18
B098AMS193700Aligned Medical SolutionsAMS19370AMS193702026-09-18
B098AMS194470Aligned Medical SolutionsAMS19447AMS194472026-09-18
B098AMS195520Aligned Medical SolutionsAMS19552AMS195522026-09-18
B098AMS195590Aligned Medical SolutionsAMS19559AMS195592026-09-18
B098AMS195760Aligned Medical SolutionsAMS19576AMS195762026-09-18
B098AMS196360Aligned Medical SolutionsAMS19636AMS196362026-09-02
B098AMS196370Aligned Medical SolutionsAMS19637AMS196372026-09-18
B098AMS196590Aligned Medical SolutionsAMS19659AMS196592026-09-18
B098AMS197450Aligned Medical SolutionsAMS19745AMS197452026-09-18
B098AMS197460Aligned Medical SolutionsAMS19746AMS197462026-09-18
B098AMS197470Aligned Medical SolutionsAMS19747AMS197472026-09-18
B098AMS197480Aligned Medical SolutionsAMS19748AMS197482026-09-18
B098AMS197520Aligned Medical SolutionsAMS19752AMS197522026-09-18
B098AMS197680Aligned Medical SolutionsAMS19768AMS197682026-09-18
B098AMS198620Aligned Medical SolutionsAMS19862AMS198622026-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS197460Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-18
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10198956494053CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956546554CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
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10198956561410CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
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10198956406964CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
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10198956498419CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956505780CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956508828CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956520493CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956547841CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10809160528334HALYARDAVID MEDICAL, INC.OHD2026-08-01
10198956368125CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956393295CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31