FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS1985B0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS1985B
Catalog number
AMS1985B
Device description
Hysteroscopy Pack
Published
2023-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
B098AMS1985B1PackageHIBCC4In Commercial Distribution
B098AMS1985B0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rectal ultrasound navigational image processorA mobile, mains electricity (AC-powered) device intended to be used in conjunction with an ultrasound imaging system and rectal ultrasound transducer to display two- and three-dimensional (3-D) ultrasound images of tissues (e.g., the prostate). It consists of a personal computer (PC) based workstation which processes data from the ultrasound imaging system, and a mechanical assembly intended to mount and track the rectal ultrasound transducer to generate a real-time 3-D image. Depending on specific software, packages may also allow for biopsy navigation and further image processing/data management.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-637-7056customerservice@alignedmedicalsolutions.com

Regulatory Flags#

DUNS number
106580145
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B098AMS14766C0Aligned Medical SolutionsAMS14766CAMS14766C2026-09-26
B098AMS186920Aligned Medical SolutionsAMS18692AMS186922026-09-26
B098AMS195170Aligned Medical SolutionsAMS19517AMS195172026-09-26
B098AMS195240Aligned Medical SolutionsAMS19524AMS195242026-09-26
B098AMS196900Aligned Medical SolutionsAMS19690AMS196902026-09-25
B098AMS197760Aligned Medical SolutionsAMS19776AMS197762026-09-16
B098AMS197870Aligned Medical SolutionsAMS19787AMS197872026-09-02
B098AMS199160Aligned Medical SolutionsAMS19916AMS199162026-09-26
B098AMS199340Aligned Medical SolutionsAMS19934AMS199342026-09-26
B098AMS199930Aligned Medical SolutionsAMS19993AMS199932026-09-26
B098AMS6160F0Aligned Medical SolutionsAMS6160FAMS6160F2026-09-26
B098AMS9487F0Aligned Medical SolutionsAMS9487FAMS9487F2026-09-26
B098AMS9509E0Aligned Medical SolutionsAMS9509EAMS9509E2026-09-26
B098DDS1159D0Aligned Medical SolutionsDDS1159DDDS1159D2026-09-26
B098AMS13148C0Aligned Medical SolutionsAMS13148CAMS13148C2026-09-22
B098AMS191960Aligned Medical SolutionsAMS19196AMS191962026-08-31
B098AMS195690Aligned Medical SolutionsAMS19569AMS195692026-09-21
B098AMS197560Aligned Medical SolutionsAMS19756AMS197562026-09-11
B098AMS198180Aligned Medical SolutionsAMS19818AMS198182026-09-11
B09AMS184330Aligned Medical SolutionsAMS18433AMS184332026-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS186920Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-26
10198956402522CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956485778CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956545953CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956547414CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956557109CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956567733CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956570764CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956587991CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956333758CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956346222CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956507807CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956539372CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956543423CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956567689CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956567801CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956570115CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956577848CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956579613CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956580558CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956581043CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956581975CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956583436CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956589216CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956439610CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956521452CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956534278CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956571488CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956576360CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
B098AMS197460Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-18