Duns Number:123853058
Device Description: Absorbable Dental Wound Dressing (10 per box)
Catalog Number
RTMTAPE10
Brand Name
Cytoplast RTM Tape
Version/Model Number
RTMTAPE10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
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
KGN
Product Code Name
Dressing, Wound, Collagen
Public Device Record Key
42ff9a96-cb55-414e-9050-56e69ec587fa
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 226 |