Duns Number:341086190
Device Description: Matrices, green, vks-oc 2.2 50 Pieces
Catalog Number
43005484
Brand Name
Matrices, green, vks-oc 2.2
Version/Model Number
43005484
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EGG
Product Code Name
ATTACHMENT, PRECISION, ALL
Public Device Record Key
f730870a-71b0-481e-88b8-700a31cf1049
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
EBRE430054849
Quantity per Package
1
Contains DI Package
EBRE430054840
Package Discontinue Date
September 21, 2016
Package Status
Not in Commercial Distribution
Package Type
dummy
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 38 |
2 | A medical device with a moderate to high risk that requires special controls. | 375 |