Duns Number:025055773
Device Description: Coldpac Denture and Repair Acrylic. Medium Fibered, 32oz.
Catalog Number
-
Brand Name
Yates Motloid Coldpac Denture and Repair Acrylic
Version/Model Number
DP3203
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
0d98f49a-22f9-42be-9dd0-5cb7c06a2bab
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
August 26, 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. | 181 |