Identity
- Trade Name
- Enteral FDA UDI
- Generic Name
- Intestinal/urinary stoma button FDA UDI
- Device Name
- Enteral, Stoma Plug, ENPLUG, Single Patient Use 10, 12, 14, 16Fr x 4cm FDA UDI
- Model / Reference
- EN-PLUG-S FDA UDI
- Description
- Enteral, Stoma Plug, ENPLUG, Single Patient Use 10, 12, 14, 16Fr x 4cm FDA UDI
Identifiers
- Catalog Number
- EN-PLUG-S FDA UDI
- Primary DI / UDI-DI
- 05060460843970 FDA UDI
- FDA Product Code
- EXE FDA UDI
- GMDN Term
- Intestinal/urinary stoma button 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
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Intestinal/urinary stoma button
Enteral by Gbuk Enteral Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intestinal/urinary stoma button.
- Enteral — GBUK ENTERAL LIMITED · Class I
- Enteral — GBUK ENTERAL LIMITED · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Gbuk Enteral Limited
Sources (1)
- FDA UDI eb524500-b622-4e6e-9762-4a9d68669917 34 fields · synced May 31, 2026