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A.M.I. Aigner Gastric Band Cutting Wires DLU

FDA UDI

Class I (US FDA UDI)

by AMI Agency for Medical Innovations GmbH

Identity

Trade Name
A.M.I. Aigner Gastric Band Cutting Wires DLU FDA UDI
Generic Name
Open-surgery dissector FDA UDI
Device Name
Cutting wire for cutting a migrated silicone gastric band FDA UDI
Model / Reference
GBC 364 FDA UDI
Description
Cutting wire for cutting a migrated silicone gastric band FDA UDI

Identifiers

Catalog Number
GBC 364 FDA UDI
Primary DI / UDI-DI
EAMIGBC3640 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

Yes

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 3.8 Meter FDA UDI
Outer Diameter — 0.5 Millimeter FDA UDI

A.M.I. Aigner Gastric Band Cutting Wires DLU 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

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Manufacturer

Manufacturer
AMI Agency for Medical Innovations GmbH

Sources (1)

  • FDA UDI 926c4f01-887d-4aef-ac14-0fb496e3229d 36 fields · synced May 30, 2026