Duns Number:080380106
Device Description: SFAM1003 ePTFE Block 1.5cm x 6cm
Catalog Number
SFAM1003
Brand Name
SFAM
Version/Model Number
SFAM1003
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
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
K021889
Product Code
KKY
Product Code Name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Public Device Record Key
f6f44f37-5195-4349-9248-d7df3f29c620
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 05, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 209 |