Duns Number:040729840
Device Description: EXPLORER/PROBE #N33-23 DOUBLE ENDED COLOR CODED/SHEPARDS HOOK TIPS LIGHT HANDLE
Catalog Number
1102-REPCN33-23
Brand Name
EXPLORER/PROBE
Version/Model Number
1102-REPCN33-23
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
c3648354-d700-402c-b6fd-a9538e550a94
Public Version Date
September 09, 2019
Public Version Number
6
DI Record Publish Date
October 09, 2018
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |