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510(k) Data Aggregation
K Number
K041080Device Name
SURGICAL DRAPE KIT - D.I.R.R.A. SRL
Manufacturer
D.I.R.R.A. S.R.L.
Date Cleared
2004-11-30
(218 days)
Product Code
LRO
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
D.I.R.R.A. S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D.I.R.R.A. surgical drape device kit is composed of natural or synthetic materials and intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination.
Device Description
The DIRRA surgical drape device kit is composed of natural or synthetic materials and intended to be used as protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination. The DIRRA surgical drape device kit is to be used by medical and dental professionals when performing surgical procedures.
The DIRRA surqical drape device kit consists of the following components: Gown w/ paper towel (2), Mayo stand cover (1), Sterile sheet (1), Patient drape (1), Transparent drape (1), Adhesive strip (4), Tube holder (1), Cord drape (2), Suction tubing w/tip (1), Flat gauze (20), Round gauze sponge (5), Plastic tray (1), Transparent adhesive film (3), Connector for suction tubing (1), Kit wrapping drape (1).
All the components are wrapped in the DIRRA surgical drape device kit wrapping drape which is closed with a label.
The final measurement of the kit (not enveloped) is approximately cm.30x30x10. The kit is then enveloped in sequence and in accordance with the instructions for use. The pack is then inserted in the Sterilization plastic/tyvek pouch and the pouch is sealed. 2 Kits are put into one cardboard box along with instructions for use,. The box is then closed and sterilized by Bioster. A sterilization batch number is applied on the box after the sterilization process has been completed.
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