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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 1/8" Pre Cut Stoma Opening flow valve and Belt Tabs FDA UDI
Model / Reference
SNS7610298 FDA UDI
Description
9" Urostomy One Piece Pouch Extended Wear Convex Transparent 1 1/8" Pre Cut Stoma Opening flow valve and Belt Tabs FDA UDI

Identifiers

Catalog Number
SNS7610298 FDA UDI
Primary DI / UDI-DI
00810040133565 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

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Manufacturer

Manufacturer
Safe N Simple Llc

Sources (1)

  • FDA UDI 85d10e62-43d5-4d29-85dc-0416513f7efc 36 fields · synced Jun 6, 2026