Duns Number:623191194
Device Description: Health-Tec/DHP Cement Spatula Flexible 24A
Catalog Number
700-1702
Brand Name
Health-Tec/DHP Hand Instruments
Version/Model Number
700-1702
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
-
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
beff4826-0b8e-4c0a-9715-fbfa18dc4431
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
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 | 464 |
2 | A medical device with a moderate to high risk that requires special controls. | 78 |