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510(k) Data Aggregation
K Number
K110954Device Name
ARJORAD STERILE WRAP
Manufacturer
ARJO WIGGINS MEDICAL, INC.
Date Cleared
2012-08-24
(507 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
ARJO WIGGINS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used to enclose another medical device that is to be sterilized. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the device until used. ArjoRad Sterilization Wraps will maintain sterility for a maximum period of thirty (30) days. Intended for use with STERRAD 100S, NX, and 100NX Systems.
Device Description
ArjoRad Sterilization Wrap is a sterilization packaging system consisting of one SMS sheet to be double wrapped during use. ArjoRad Sterilization Wrap will be sold in a non-sterile condition in packaged form of various sizes depending on the needs of the end user.
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K Number
K062100Device Name
ARJOWRAP 47/100 AND 47/88
Manufacturer
ARJO WIGGINS MEDICAL, INC.
Date Cleared
2006-12-05
(134 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
ARJO WIGGINS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ArjoWrap 47/100 and ArjoWrap 47/88 models are single use, non-sterilization wraps intended to be used by healthcare facilities to wrap other medical devices for terminal sterilization by steam or ethylene oxide. ArjoWrap 47/100 and ArjoWrap 47/88 maintain the sterility of the enclosed devices until they are used.
ArjoWrap 47/100 and ArjoWrap 47/88 are not recommended for any type of irradiation sterilization.
Device Description
ArjoWrap is a sterilization wrap to be used by healthcare facilities to wrap other medical devices for terminal sterilization by steam or ethylene oxide. The ArjoWrap product is composed of two materials and will be offered two different weights. Each weight will be markcted in twelve sizes.
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