Duns Number:623191194
Device Description: Health-Tec/DHP Probe Color Coded CP11 (3-6-8-11mm)
Catalog Number
700-1600
Brand Name
Health-Tec/DHP Hand Instruments
Version/Model Number
700-1600
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
EIX
Product Code Name
Probe, Periodontic
Public Device Record Key
76ea07ff-59dc-424d-98c1-a5aa7d1bb373
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 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 |