FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
B098AMS3607A0
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
AMS3607A
Catalog number
AMS3607A
Device description
Custom Pack
Published
2019-06-18
Public version status
Update
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
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
B098AMS3607A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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@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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B098AMS169560Aligned Medical SolutionsAMS16956AMS169562026-08-25
B098AMS17108C0Aligned Medical SolutionsAMS17108CAMS17108C2026-08-23
B098AMS17526A0Aligned Medical SolutionsAMS17526AAMS17526A2026-08-23
B098AMS185880Aligned Medical SolutionsAMS18588AMS185882026-08-21
B098AMS189100Aligned Medical SolutionsAMS18910AMS189102026-08-21
B098AMS190500Aligned Medical SolutionsAMS19050AMS190502026-08-21
B098AMS190740Aligned Medical SolutionsAMS19074AMS190742026-08-21
B098AMS190750Aligned Medical SolutionsAMS19075AMS190752026-08-21
B098AMS190760Aligned Medical SolutionsAMS19076AMS190762026-08-21
B098AMS192350Aligned Medical SolutionsAMS19235AMS192352026-08-21
B098AMS197320Aligned Medical SolutionsAMS19732AMS197322026-08-19
B098AMS188850Aligned Medical SolutionsAMS18885AMS188852026-08-17
B098AMS191930Aligned Medical SolutionsAMS19193AMS191932026-08-17
B098AMS14529C0Aligned Medical SolutionsAMS14529CAMS14529C2026-08-14
B098AMS14762A0Aligned Medical SolutionsAMS14762AAMS14762A2026-08-16
B098AMS17107C0Aligned Medical SolutionsAMS17107CAMS17107C2026-08-14
B098AMS17337A0Aligned Medical SolutionsAMS17337AAMS17337A2026-08-14
B098AMS17686A0Aligned Medical SolutionsAMS17686AAMS17686A2026-08-14
B098AMS18377A0Aligned Medical SolutionsAMS18377AAMS18377A2026-08-16
B098AMS188840Aligned Medical SolutionsAMS18884AMS188842026-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160531860HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531877HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531914HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531921HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531945HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531952HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531976HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531983HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160531990HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532010HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532034HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532041HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532058HalyardAVID MEDICAL, INC.LRO2026-08-27
10809160532089HalyardAVID MEDICAL, INC.LRO2026-08-27
10198956437746CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956504462CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956509078CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956511163CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956523814CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956524446CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956531703CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956534896CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956534971CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956535107CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956535473CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956537576CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956544499CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956547636CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956548404CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26
10198956549937CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-26