Duns Number:315018218
Device Description: MATRIX SEPARATOR F.STRIPS UP TO 7MM
Catalog Number
DF348R
Brand Name
AESCULAP
Version/Model Number
DF348R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 23, 2021
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
EKF
Product Code Name
INSTRUMENT, CONTOURING, MATRIX, OPERATIVE
Public Device Record Key
7774ffc5-2560-467d-b128-a1d351c6d5ff
Public Version Date
May 21, 2021
Public Version Number
2
DI Record Publish Date
May 07, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |