Duns Number:315731711
Device Description: 7571S VITREBOND PLUS LIGHT CURE GI LINER/BASE - Sample Pack
Catalog Number
7571S
Brand Name
Vitrebond™
Version/Model Number
7571S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 13, 2017
Issuing Agency
In HIBCC
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
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
728ac195-a63c-43c6-9ee5-2217ca3e5785
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
H44457412580
Quantity per Package
10
Contains DI Package
H44457412140
Package Discontinue Date
February 13, 2017
Package Status
Not 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 | 232 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 563 |
| U | Unclassified | 3 |