4 results
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16ms
·
Sources: EU EUDAMED, US FDA
882.4360
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBB·October 3, 2012
882.4360
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBE·September 19, 2012
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 6, 2019
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet¿ Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.
FDA Enforcement
Class II
·Ongoing·MicroSurgical Technology Inc·December 4, 2024