← Back to catalogue

Safe N Simple

FDA UDI

Class I (US FDA UDI)

by Safe N Simple Llc

Identity

Trade Name
Safe N Simple FDA UDI
Generic Name
One-piece urostomy bag, open-ended FDA UDI
Device Name
9" Urostomy One Piece Pouch Extended Wear Convex Transparent 1" Pre Cut Stoma Opening with valve and Belt Tabs FDA UDI
Model / Reference
SNS7610258 FDA UDI
Description
9" Urostomy One Piece Pouch Extended Wear Convex Transparent 1" Pre Cut Stoma Opening with valve and Belt Tabs FDA UDI

Identifiers

Catalog Number
SNS7610258 FDA UDI
Primary DI / UDI-DI
00810040133527 FDA UDI
FDA Product Code
EXG FDA UDI
GMDN Term
One-piece urostomy bag, open-ended FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 9 Inch FDA UDI

Category: One-piece urostomy bag, open-ended

Safe N Simple by Safe N Simple Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as One-piece urostomy bag, open-ended.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Safe N Simple Llc

Sources (1)

  • FDA UDI 3a8f0c6f-2b89-43cb-9a14-cb7f0020e3ac 36 fields · synced May 30, 2026