Duns Number:005473608
Device Description: EXAFLEX® Putty 1-1 Pack (1 x 500g blue base Jar, 1 x 500g yellow catalyst Jar, 2 x scoops)
Catalog Number
138301
Brand Name
EXAFLEX®
Version/Model Number
138301
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K955932,K955932
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
bd0c49d2-d8ef-4d5d-a7c4-11e141667055
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 01, 2016
Package DI Number
D6581383012
Quantity per Package
6
Contains DI Package
D6581383011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |