FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS197690
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS19769
Catalog number
AMS19769
Device description
Instrument Tray
Published
2026-10-23
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
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098AMS197690PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
B098AMS12195E0Aligned Medical SolutionsAMS12195EAMS12195E2026-10-23
B098AMS16041C0Aligned Medical SolutionsAMS16041CAMS16041C2026-10-02
B098AMS16179A0Aligned Medical SolutionsAMS16179AAMS16179A2026-10-23
B098AMS173690Aligned Medical SolutionsAMS17369AMS173692026-10-23
B098AMS188920Aligned Medical SolutionsAMS18892AMS188922026-10-23
B098AMS191190Aligned Medical SolutionsAMS19119AMS191192026-10-23
B098AMS191900Aligned Medical SolutionsAMS19190AMS191902026-10-23
B098AMS19291A0Aligned Medical SolutionsAMS19291AAMS19291A2026-10-23
B098AMS194040Aligned Medical SolutionsAMS19404AMS194042026-10-23
B098AMS194050Aligned Medical SolutionsAMS19405AMS194052026-10-23
B098AMS199310Aligned Medical SolutionsAMS19931AMS199312026-10-23
B098AMS199320Aligned Medical SolutionsAMS19932AMS199322026-10-23
B098AMS199620Aligned Medical SolutionsAMS19962AMS199622026-10-23
B098AMS199880Aligned Medical SolutionsAMS19988AMS199882026-10-23
B098AMS199890Aligned Medical SolutionsAMS19989AMS199892026-10-23
B098AMS201510Aligned Medical SolutionsAMS20151AMS201512026-10-23
B098AMS186900Aligned Medical SolutionsAMS18690AMS186902026-10-19
B098AMS188100Aligned Medical SolutionsAMS18810AMS188102026-08-31
B098AMS195290Aligned Medical SolutionsAMS19529AMS195292026-10-02
B098AMS189300Aligned Medical SolutionsAMS18930AMS189302026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956592568CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956593886CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956603592CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956611856CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956612815CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956612921CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956619203CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956620957CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956623286CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
10198956623507CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-23
03661219327929LANDANGERLANDANGERLRP2026-10-22
10198956558793CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956572447CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956578470CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956589575CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956599901CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956604216CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956611450CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956611863CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956617384CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
10198956619241CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-19
00810161900992EARP, IMPLANT CADDY 14X25RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901005EARP, IMPLANT LID 14X25RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901012EARP, IMPLANT CADDY 14X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901029EARP, IMPLANT LID 14X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901036EARP, IMPLANT CADDY 14X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901043EARP, IMPLANT LID 14X35RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901050EARP, IMPLANT CADDY 14X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901067EARP, IMPLANT LID 14X40RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16
00810161901074EARP, IMPLANT CADDY 18X30RETROPSOAS TECHNOLOGIES, LLCLRP2026-10-16