Duns Number:436650394
Device Description: Vinylpolisiloxane for impressions
Catalog Number
055210
Brand Name
PRESTIGE MONOPHASE 2 X 50 ML
Version/Model Number
055210
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K022653,K022653
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
be55fa40-a12c-40b0-949a-a7af5847b957
Public Version Date
July 01, 2021
Public Version Number
2
DI Record Publish Date
September 06, 2019
Package DI Number
58033712562228
Quantity per Package
29
Contains DI Package
08033712562223
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |