Identity
- Trade Name
- SteriGear FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Fig Leaf Low 15 1500ml 10287 FDA UDI
- Model / Reference
- UE4001-00 FDA UDI
- Description
- Fig Leaf Low 15 1500ml 10287 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851616002571 FDA UDI
- FDA Product Code
- FCN FDA UDI
- GMDN Term
- Non-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
Ethylene Oxide FDA UDI
Category: Non-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 Non-wearable adult urine collection bag, open-ended.
- RUSCH — TELEFLEX INCORPORATED · Class II
- AMSure® Urinary Drainage Bag — AMSINO INTERNATIONAL, INC. · Class II
- MedPride — SHIELD-LINE, LLC · Class II
- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 18" — UROCARE PRODUCTS, INC. · Class I
- Urocare® Tubing White-Rubber with Connector and Clamp 0.31" x 18" — UROCARE PRODUCTS, INC. · Class II
- Conveen Standard — Coloplast A/S · Class I
- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60" — UROCARE PRODUCTS, INC. · Class I
- ASP MEDICAL — Asp Global, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterigear, LLC
Sources (1)
- FDA UDI 11bf8c2b-eb2a-4c9f-911a-651ffa6a20ea 35 fields · synced May 30, 2026