Identity
- Trade Name
- A.M.I. Flexible Wire Guide FDA UDI
- Generic Name
- Open-surgery dissector FDA UDI
- Device Name
- Wire guide for cutting a migrated silicone gastric band FDA UDI
- Model / Reference
- GBC 363 FDA UDI
- Description
- Wire guide for cutting a migrated silicone gastric band FDA UDI
Identifiers
- Catalog Number
- GBC 363 FDA UDI
- Primary DI / UDI-DI
- EAMIGBC3630 FDA UDI
- FDA Product Code
- FZT FDA UDI
- GMDN Term
- Open-surgery dissector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 1000 Millimeter FDA UDIOuter Diameter — 4.5 Millimeter FDA UDILumen/Inner Diameter — 0.8 Millimeter FDA UDI
A.M.I. Flexible Wire Guide by AMI Agency for Medical Innovations GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- AMI Agency for Medical Innovations GmbH
Sources (1)
- FDA UDI 0d219001-26ee-4a6b-b3ab-d7092e3e91cc 36 fields · synced May 30, 2026