FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
00850064198522
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
PRO90221
Catalog number
PRO90221
Device description
Gown Surgical Fabric Reinforced LG
Published
2025-03-05
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
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
10850064198529PackageGS120In Commercial Distribution
00850064198522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006419852910850064198529
00850064198522008500641985228500641985220850064198522

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 Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-637-7056customerservice@alignedmedical.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
00850064198676Aligned Medical SolutionsMISX-6F07MISX-6F072026-07-17
00850064198683Aligned Medical SolutionsMISX-7F07MISX-7F072026-07-17
B098AMS11096B0Aligned Medical SolutionsAMS11096BAMS11096B2026-07-19
B098AMS188250Aligned Medical SolutionsAMS18825AMS188252026-07-19
B098AMS192180Aligned Medical SolutionsAMS19218AMS192182026-07-19
B098AMS192900Aligned Medical SolutionsAMS19290AMS192902026-07-19
B098AMS12381C0Aligned Medical SolutionsAMS12381CAMS12381C2026-07-12
B098AMS14885C0Aligned Medical SolutionsAMS14885CAMS14885C2026-07-12
B098AMS17983A0Aligned Medical SolutionsAMS17983AAMS17983A2026-07-12
B098AMS18306A0Aligned Medical SolutionsAMS18306AAMS18306A2026-07-12
B098AMS184440Aligned Medical SolutionsAMS18444AMS184442026-07-12
B098AMS190580Aligned Medical SolutionsAMS19058AMS190582026-07-12
B098AMS192890Aligned Medical SolutionsAMS19289AMS192892026-07-12
B098AMS192920Aligned Medical SolutionsAMS19292AMS192922026-07-12
B098AMS193400Aligned Medical SolutionsAMS19340AMS193402026-07-12
B098AMS8144C0Aligned Medical SolutionsAMS8144CAMS8144C2026-07-12
B098AMS10930A0Aligned Medical SolutionsAMS10930AAMS10930A2026-07-03
B098AMS16803A0Aligned Medical SolutionsAMS16803AAMS16803A2026-07-03
B098AMS180170Aligned Medical SolutionsAMS18017AMS180172026-07-03
B098AMS193380Aligned Medical SolutionsAMS19338AMS193382026-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS192900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-19
10809160527177HALYARDAVID MEDICAL, INC.LRO2026-07-17
10809160527313HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527320HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527344HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527351HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527368HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527399HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527405HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527412HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527443HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527450HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527467HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527474HalyardAVID MEDICAL, INC.LRO2026-07-17
10809160527481HalyardAVID MEDICAL, INC.LRO2026-07-17
10198956344020CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956418431CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956439887CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956444386CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956462175CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956472105CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477391CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956479845CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956483439CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956488304CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956502437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956504868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956507982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956508149CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16