Search results with tag "Sterile package"
MDR Labelling Requirements - Medical Device Regulation
www.medical-device-regulation.eu•Sterile package requirements (23.3) • AIMDD already distinguishes sterile pack from trade pack / sales pack; this distinction is new to MDD devices • Mostly a sub-set of existing labelling requirements •“an indication permitting the sterile packaging to be recognized as such,”–i.e. disclaimers, sterile symbol,
![Tendril STS 2088 [OUS] - St. Jude Medical Instructions for ...](/cache/preview/0/1/6/5/9/9/f/b/thumb-016599fbc524e50a7f361018615dac17.jpg)
Tendril STS 2088 [OUS] - St. Jude Medical Instructions for ...
manuals.sjm.com1. Inside sterile field : Sterilization The package contents have been sterilized with ethylene oxide before shipment. This lead is for single use only and is not intended to be resterilized. If the sterile package has been compromised, contact St. Jude Medical. Implanting the Tendril™ STS Lead : Pre-Implantation : Before implanting the lead:
General Safety and Performance Requirements (Annex I) in ...
www.bsigroup.comMedical Device Regulation Comparison with the Essential Requirements of the Medical Device Directive and Active Implantable Device Directive ... SPR 23.3: Sterile package label requirements 17 SPR 23.4: Instructions for Use 18 Absent in SPR list: Clinical evaluation, medicinal consultation 20 ...
User's Manual - St. Jude Medical Instructions for Use Website
manuals.sjm.comThe device and the incision and insertion tools have been sterilized with ethylene oxide prior to shipment. They are intended for single use only and should not be resterilized. If the sterile package has been compromised, contact St. Jude Medical. Do not insert the device if the dot on the ethylene oxide label is purple.