FDA.reportPublic FDA data

Safe N Simple

Primary DI
00810040135187
Brand
Safe N Simple
Company
SAFE N' SIMPLE LLC
Model
SNS7501134-NF
Catalog number
SNS7501134-NF
Device description
"9"" Urostomy 2-Piece Pouch Beige 50 mm 2"" Flange with Valve and Belt Tabs"
Published
2024-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXGBag, Urine Collecting, Ureterostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXGBag, Urine Collecting, UreterostomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040135187PrimaryGS10
00810040135163Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040135187008100401351878100401351870810040135187
00810040135163008100401351638100401351630810040135163

Contacts#

Phone, Email table
PhoneEmail
248 214 4877tsajan@sns-medical.com

Regulatory Flags#

DUNS number
807812412
Device count
80
Premarket exempt
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
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
00810040135613Safe N Simple LLCSNS21630SNS216302026-10-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970944382392OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-31
06970944382583OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-30
06970944382415OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-27
06970944383740OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-27
06970944383757OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-09
06974795055948MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
06974795058116MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
06974795059199MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
00810040135170Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135248Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135255Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135293Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135309Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135163Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135231Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135286Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
06974567745886EMSRUNWuxi Emsrun Technology Co., Ltd.EXG2024-05-22
16974567745883EMSRUNWuxi Emsrun Technology Co., Ltd.EXG2024-05-22
10768455204530ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204547ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204615ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204622ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204639ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204646ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204653ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204660ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204677ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204714ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204721ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204745ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20