Duns Number:015108087
Device Description: Gibson Healthcare Endo Irrigation Single Canal Kit. Contains: (1) 10ml pre-filled sodium h Gibson Healthcare Endo Irrigation Single Canal Kit. Contains: (1) 10ml pre-filled sodium hypochlorite syringe, (1) 3ml pre-filled EDTA syringe, (1) 3ml pre-filled 95% ethyl alcohol syringe, (1) 3ml pre-filled chlorhexidine syringe, (4) 30g irrigation needle tips, (1) canal aspiratior with tip.
Catalog Number
-
Brand Name
GIBSON HEALTHCARE
Version/Model Number
5126-301
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KJJ
Product Code Name
Cleanser, Root Canal
Public Device Record Key
68253ab5-6c40-4390-b414-816d798aec3a
Public Version Date
May 06, 2020
Public Version Number
2
DI Record Publish Date
September 19, 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 | 1364 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 377 |
| U | Unclassified | 15 |