Duns Number:008999906
Device Description: The Teirstein Edge Device Organizer is intended to stabilize and load guidewires and cathe The Teirstein Edge Device Organizer is intended to stabilize and load guidewires and catheters during percutaneous procedures.
Catalog Number
-
Brand Name
Teirstein Edge™ device organizer
Version/Model Number
8150
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
-
Product Code
FTY
Product Code Name
Tape, Measuring, Rulers And Calipers
Public Device Record Key
6c5df596-e111-4ab0-87e8-94910e0c202e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 05, 2016
Package DI Number
M20681501
Quantity per Package
10
Contains DI Package
M20681500
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |