Duns Number:008486367
Device Description: Gantry Guard Flex Mini also called Gantry Guard Mini -- CT Gantry Cover with Adhesive Tabs Gantry Guard Flex Mini also called Gantry Guard Mini -- CT Gantry Cover with Adhesive Tabs, 1.6mil LDPE, 109 x 82 inches, Clear, 25/Bx
Catalog Number
CTG03
Brand Name
Gantry Guard Flex Mini
Version/Model Number
CTG03
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 12, 2020
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
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
54094a79-dbed-443b-8464-f1838a895b1e
Public Version Date
March 13, 2020
Public Version Number
4
DI Record Publish Date
April 25, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-