Duns Number:353939929
Device Description: creos™ syntoprotect PTFE membrane 200 12 x 24 mm. Also available in a pack of 10 with cata creos™ syntoprotect PTFE membrane 200 12 x 24 mm. Also available in a pack of 10 with catalog number N161224-10, as creos™ syntoprotect PTFE membrane 200 12 x 24 mm 10x.
Catalog Number
N161224-1
Brand Name
creos™ syntoprotect
Version/Model Number
N161224-1
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
-
Product Code
LYC
Product Code Name
Bone grafting material, synthetic
Public Device Record Key
8e0dacb9-201f-45c4-9e90-2d7e3b1b2770
Public Version Date
January 21, 2021
Public Version Number
1
DI Record Publish Date
January 13, 2021
Package DI Number
17332747181866
Quantity per Package
10
Contains DI Package
07332747181869
Package Discontinue Date
-
Package Status
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 | 782 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3680 |