Duns Number:480420090
Device Description: PLASTIC PIPETTES ENDO 0.3mL - 5 piecesOne assortment of 5 color-coded pipetteFor introduc PLASTIC PIPETTES ENDO 0.3mL - 5 piecesOne assortment of 5 color-coded pipetteFor introducing solutions into the root canal or cavities
Catalog Number
-
Brand Name
PLASTIC PIPETTES 0.3mL - 5 pieces
Version/Model Number
11750
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
Yes
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
EIC
Product Code Name
Syringe, Periodontic, Endodontic, Irrigating
Public Device Record Key
547e8fb5-29ec-4456-970d-7a0176b5dbc4
Public Version Date
June 23, 2022
Public Version Number
1
DI Record Publish Date
June 15, 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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |