Identity
- Trade Name
- A.M.I. Aigner Gastric Band Cutter FDA UDI
- Generic Name
- Open-surgery dissector FDA UDI
- Device Name
- Instrument for cutting a migrated silicone gastric band FDA UDI
- Model / Reference
- GBC 360 FDA UDI
- Description
- Instrument for cutting a migrated silicone gastric band FDA UDI
Identifiers
- Catalog Number
- GBC 360 FDA UDI
- Primary DI / UDI-DI
- EAMIGBC3600 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
A.M.I. Aigner Gastric Band Cutter 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 b876a60a-0ef0-4793-a025-480d6b39c59f 35 fields · synced Jun 6, 2026