Duns Number:009900424
Device Description: Parkell® Universal Adhesive Kit
Catalog Number
S264
Brand Name
Parkell®
Version/Model Number
S264
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 16, 2020
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
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
88826b04-fed4-4e23-a2e3-313a4dd8d8c1
Public Version Date
November 24, 2020
Public Version Number
2
DI Record Publish Date
October 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 | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 476 |
U | Unclassified | 19 |