Duns Number:005085972
Device Description: #24 Cement Spatula
Catalog Number
CS24
Brand Name
HU-FRIEDY
Version/Model Number
CS24
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
-
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
GAF
Product Code Name
SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
d2bf7910-574e-4ac7-a322-2be3dd42d84f
Public Version Date
November 20, 2020
Public Version Number
1
DI Record Publish Date
November 12, 2020
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7436 |
2 | A medical device with a moderate to high risk that requires special controls. | 238 |