Duns Number:040729840
Device Description: KIRLAND PERIODONTAL CURETTE #13-13L DOUBLE ENDED BLADES LIGHT HANDLE
Catalog Number
1102-RECPK13-13L
Brand Name
KIRLAND PERIODONTAL CURETTE
Version/Model Number
1102-RECPK13-13L
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
EMK
Product Code Name
CURETTE, SURGICAL, DENTAL
Public Device Record Key
962cec12-031e-4e7b-b5bb-7042816e6698
Public Version Date
September 09, 2019
Public Version Number
8
DI Record Publish Date
September 21, 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 |