Duns Number:038023573
Device Description: Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb
Catalog Number
C03-0201
Brand Name
Cytoflex Resorb
Version/Model Number
20x25mm
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
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
K090083
Product Code
NPK
Product Code Name
Barrier, Synthetic, Intraoral
Public Device Record Key
4ef69d60-26c2-4d10-a78a-15b949796aad
Public Version Date
July 27, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2015
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. | 11 |
| U | Unclassified | 1 |