FDA.reportPublic FDA data

Safe N Simple LLC

Primary DI
00810040135613
Brand
Safe N Simple LLC
Company
SAFE N' SIMPLE LLC
Model
SNS21630
Catalog number
SNS21630
Device description
Ostomy Skin Barrier Arcs 1" with Aloe and Zinc
Published
2026-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EZRCement, Stomal Appliance, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZRCement, Stomal Appliance, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040135613PrimaryGS10
00810040135606Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040135613008100401356138100401356130810040135613
00810040135606008100401356068100401356060810040135606

GMDN Terms#

Term, Definition table
TermDefinition
Patient medical adhesive removerA liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
807812412
Device count
30
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
00810040130403Safe N Simple LLCSNS684D2SNS684D22026-10-15
00810040130410Safe N Simple LLCSNS684D2SNS684D22026-10-15
00810040130496Safe N Simple LLCSNS21615SNS216152026-10-15
00810040130502Safe N Simple LLCSNS21615SNS216152026-10-15
00810040134265Safe N Simple LLCSNS7135005SNS71350052026-10-15
00810040134296Safe N Simple LLCSNS7126049SNS71260492026-10-15
00810040134302Safe N Simple LLCSNS7135005SNS71350052026-10-15
00810040134326Safe N Simple LLCSNS7153005SNS71530052026-10-15
00810040134333Safe N Simple LLCSNS7153005SNS71530052026-10-15
00810040135583Safe N Simple LLCSNS21222SNS212222026-10-15
00810040135590Safe N Simple LLCSNS21222SNS212222026-10-15
00810040135620Safe N Simple LLCSNS21630SNS216302026-10-15
00810040135644Safe N Simple LLCSNS21113SNS211132026-10-15
00810040135651Safe N Simple LLCSNS21113SNS211132026-10-15
00810040135675Safe N Simple LLCSNS68112SNS681122026-10-15
00810040135682Safe N Simple LLCSNS68112SNS681122026-10-15
00850002835007Safe N Simple LLCSNS14506SNS145062026-10-15
00850002835014Safe N Simple LLCSNS14506SNS145062026-10-15
00850002835021Safe N Simple LLCSNS14502SNS145022026-10-15
00850002835038Safe N Simple LLCSNS14502SNS145022026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810040130403Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040130410Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040130496Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040130502Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040134265Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040134296Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040134302Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040134326Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040134333Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040135583Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040135590Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040135620Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040135644Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040135651Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040135675Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00810040135682Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835007Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835014Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835021Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835038Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835069Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835076Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835083Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835090Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835113Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835175Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835182Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835236Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835335Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15
00850002835342Safe N Simple LLCSAFE N' SIMPLE LLCEZR2026-10-15