Duns Number:038023573
Device Description: Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in gui
Catalog Number
C04-0101
Brand Name
Cytoflex Textured Tef-Guard
Version/Model Number
TEX-100
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
K012144,K012144
Product Code
NPK
Product Code Name
Barrier, Synthetic, Intraoral
Public Device Record Key
f3430b1f-83d4-4971-b1c8-c6667dc7d64e
Public Version Date
July 27, 2021
Public Version Number
4
DI Record Publish Date
November 23, 2016
Package DI Number
D767C0401051
Quantity per Package
5
Contains DI Package
D767C0401010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
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 |