FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098TAU1007A1
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
TAU1007A
Catalog number
TAU1007A
Device description
Vein Tray
Published
2018-11-14
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B098TAU1007A1PackageHIBCC8In Commercial Distribution
B098TAU1007A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)637-7056customerservice@alignedmedical
+1(888)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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B098AMS10132C0Aligned Medical SolutionsAMS10132CAMS10132C2026-08-03
B098AMS16817B0Aligned Medical SolutionsAMS16817BAMS16817B2026-08-03
B098AMS17579A0Aligned Medical SolutionsAMS17579AAMS17579A2026-08-03
B098AMS178930Aligned Medical SolutionsAMS17893AMS178932026-08-03
B098AMS178970Aligned Medical SolutionsAMS17897AMS178972026-08-03
B098AMS186950Aligned Medical SolutionsAMS18695AMS186952026-08-03
B098AMS188600Aligned Medical SolutionsAMS18860AMS188602026-08-03
B098AMS191170Aligned Medical SolutionsAMS19117AMS191172026-08-03
B098AMS12325E0Aligned Medical SolutionsAMS12325EAMS12325E2026-07-27
B098AMS167810Aligned Medical SolutionsAMS16781AMS167812026-07-27
B098AMS190780Aligned Medical SolutionsAMS19078AMS190782026-07-27
B098AMS9909C0Aligned Medical SolutionsAMS9909CAMS9909C2026-07-27
B098AMS131940Aligned Medical SolutionsAMS13194AMS131942026-07-26
B098AMS131950Aligned Medical SolutionsAMS13195AMS131952026-07-26
B098AMS131960Aligned Medical SolutionsAMS13196AMS131962026-07-25
B098AMS13932C0Aligned Medical SolutionsAMS13932CAMS13932C2026-07-25
B098AMS14766B0Aligned Medical SolutionsAMS14766BAMS14766B2026-07-26
B098AMS16019B0Aligned Medical SolutionsAMS16019BAMS16019B2026-07-25
B098AMS17798A0Aligned Medical SolutionsAMS17798AAMS17798A2026-07-26
B098AMS17843A0Aligned Medical SolutionsAMS17843AAMS17843A2026-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160529447HalyardAVID MEDICAL, INC.LRO2026-08-08
10809160529188HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529195HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529201HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529225HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529232HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529249HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529256HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529263HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529270HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529287HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529294HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529300HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529317HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529324HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529348HalyardAVID MEDICAL, INC.LRO2026-08-07
10809160529355HalyardAVID MEDICAL, INC.LRO2026-08-07
10885632529412SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10885632529429SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10885632529436SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-07
10809160528365HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528372HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528389HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528419HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528433HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528440HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528457HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528488HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528495HalyardAVID MEDICAL, INC.LRO2026-08-03
10809160528501HalyardAVID MEDICAL, INC.LRO2026-08-03