Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Gastrostomy button FDA UDI
- Device Name
- Gastrostomy Button G1I 0.8cm 20Fr ENFit Big Blis FDA UDI
- Model / Reference
- 103310012089MD FDA UDI
- Description
- Gastrostomy Button G1I 0.8cm 20Fr ENFit Big Blis FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290110061470 FDA UDI
- FDA Product Code
- PSH FDA UDI
- GMDN Term
- Gastrostomy button FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
MR Conditional FDA UDI
Category: Gastrostomy button
Medline by Degania Silicone Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mini ONE® Non-Balloon Button — Applied Medical Technology, Inc. · Class II
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 |
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Manufacturer
- Manufacturer
- Degania Silicone Ltd
Sources (1)
- FDA UDI a55db456-cfbd-4e3b-ac38-e60de73c9d00 33 fields · synced May 30, 2026