FDA.reportPublic FDA data

Aligned Medical Solutions

Primary DI
00850064198751
Brand
Aligned Medical Solutions
Company
Aligned Medical Solutions
Model
19254S
Catalog number
19254S
Device description
Gown Sleeve 2/PK
Published
2026-09-23
Public version status
Update
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
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850064198758PackageGS1100In Commercial Distribution
00850064198751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085006419875810850064198758
00850064198751008500641987518500641987510850064198751

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-800-637-7056customerservice@alignedmedical.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
B098AMS186900Aligned Medical SolutionsAMS18690AMS186902026-10-19
B098AMS188100Aligned Medical SolutionsAMS18810AMS188102026-08-31
B098AMS195290Aligned Medical SolutionsAMS19529AMS195292026-10-02
B098AMS189300Aligned Medical SolutionsAMS18930AMS189302026-09-18
B098AMS13351C0Aligned Medical SolutionsAMS13351CAMS13351C2026-10-16
B098AMS14994B0Aligned Medical SolutionsAMS14994BAMS14994B2026-10-16
B098AMS15543A0Aligned Medical SolutionsAMS15543AAMS15543A2026-10-16
B098AMS16588B0Aligned Medical SolutionsAMS16588BAMS16588B2026-10-16
B098AMS16589C0Aligned Medical SolutionsAMS16589CAMS16589C2026-10-16
B098AMS16935A0Aligned Medical SolutionsAMS16935AAMS16935A2026-10-16
B098AMS17680A0Aligned Medical SolutionsAMS17680AAMS17680A2026-10-16
B098AMS18304A0Aligned Medical SolutionsAMS18304AAMS18304A2026-10-16
B098AMS197790Aligned Medical SolutionsAMS19779AMS197792026-10-16
B098AMS197520Aligned Medical SolutionsAMS19752AMS197522026-09-18
B098AMS1218F0Aligned Medical SolutionsAMS1218FAMS1218F2026-10-14
B098AMS14689D0Aligned Medical SolutionsAMS14689DAMS14689D2026-10-14
B098AMS14856B0Aligned Medical SolutionsAMS14856BAMS14856B2026-10-14
B098AMS16398B0Aligned Medical SolutionsAMS16398BAMS16398B2026-10-14
B098AMS17118A1Aligned Medical SolutionsAMS17118AAMS17118A2026-10-14
B098AMS17481A0Aligned Medical SolutionsAMS17481AAMS17481A2026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756401753DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401760DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401777DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401784DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00850078013101MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013118MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013125MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013132MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013149MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00840456224571JMUJMU DENTAL, INCLYU2026-08-18
00840456224588JMUJMU DENTAL, INCLYU2026-08-18
00840456224595JMUJMU DENTAL, INCLYU2026-08-18
00840456224601JMUJMU DENTAL, INCLYU2026-08-18
00840456224618JMUJMU DENTAL, INCLYU2026-08-18
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06