Duns Number:506826739
Device Description: Curette "Gracey Small" # 11-12COMFORT SL double ended
Catalog Number
-
Brand Name
Reicodent
Version/Model Number
02-GRS 11-12 C
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
EMS
Product Code Name
Curette, Periodontic
Public Device Record Key
a0c36968-789b-40ab-aebb-dd4b6093fc9e
Public Version Date
April 16, 2020
Public Version Number
1
DI Record Publish Date
April 08, 2020
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 | 2521 |