Duns Number:116723413
Device Description: One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life. The Viscera Retainer is made up of green plastic and is flat on one side with ribs on the other to support placement in viscera region with a over molded radiopaque center spine up the middle of the unit for additional support for placement and extraction. The retainer has an attached pull cord and ring for easy removal when suturing is about complete.
Catalog Number
RMD3206
Brand Name
Viscera Retainer Radiopaque Center Spine
Version/Model Number
Large
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCZ
Product Code Name
Retainer, Surgical
Public Device Record Key
009e3eee-be27-4ebf-9333-558620ab9ba8
Public Version Date
February 15, 2019
Public Version Number
1
DI Record Publish Date
January 15, 2019
Package DI Number
00857180007639
Quantity per Package
150
Contains DI Package
00857180007615
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugate box