A.M.I. Aigner Gastric Band Cutting Wires DLU GBC 364

GUDID EAMIGBC3640

Cutting wire for cutting a migrated silicone gastric band

AMI Agency for Medical Innovations GmbH

Open-surgery dissector
Primary Device IDEAMIGBC3640
NIH Device Record Key926c4f01-887d-4aef-ac14-0fb496e3229d
Commercial Distribution StatusIn Commercial Distribution
Brand NameA.M.I. Aigner Gastric Band Cutting Wires DLU
Version Model NumberGBC 364
Catalog NumberGBC 364
Company DUNS303655286
Company NameAMI Agency for Medical Innovations GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter
Length3.8 Meter
Outer Diameter0.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEAMIGBC3640 [Primary]

FDA Product Code

FZTCutter, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


[EAMIGBC3640]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-31
Device Publish Date2018-11-28

Devices Manufactured by AMI Agency for Medical Innovations GmbH

EAMIMCS55110 - More-Cell-System2021-12-17 More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery t
EAMIMCS55311 - More-Cell Bag2021-12-17 More-Cell Bag is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to e
MCS55511 - More-Cell-System 302021-12-17 More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgeryto
EAMIAFC1000 - A.M.I. FasciaCutter Disposable Instrument2020-02-06 The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is used to for enlargement of trocar incisio
EAMIA054920 - A.M.I.-dock Applicator Short 5mm 2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm. The A.M.I.-dock Applicator serves as endoscopic m
EAMIA054930 - A.M.I.-dock Applicator Curved 5mm2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 5mm. The A.M.I.-dock Applicator serves as endoscopic c
EAMIA101110 - A.M.I.-dock Applicator Standard 10mm2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm. The A.M.I.-dock Applicator serves as endoscopic
EAMIA101120 - A.M.I.-dock Applicator Short 10mm2019-04-23 Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm. The A.M.I.-dock Applicator serves as endoscopic

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.