← Back to catalogue

SteriGear

FDA UDI

Class II (US FDA UDI)

by Sterigear, LLC

Identity

Trade Name
SteriGear FDA UDI
Generic Name
Wearable adult urine collection bag, open-ended FDA UDI
Device Name
Fig Leaf Leg Bag 10272 FDA UDI
Model / Reference
UE4001-00 FDA UDI
Description
Fig Leaf Leg Bag 10272 FDA UDI

Identifiers

Primary DI / UDI-DI
00851616002038 FDA UDI
FDA Product Code
FCN FDA UDI
GMDN Term
Wearable adult urine collection bag, open-ended FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Wearable adult urine collection bag, open-ended

SteriGear by Sterigear, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable adult urine collection 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
Sterigear, LLC

Sources (1)

  • FDA UDI 93bfa60c-6c01-47c4-af4b-5ebd16135d91 35 fields · synced May 29, 2026