Duns Number:020198912
Device Description: Small Curl Catheter Introducer Sheath 11.5 OD/8.5F ID, 8.5F dilator, 94cm dilator length, Small Curl Catheter Introducer Sheath 11.5 OD/8.5F ID, 8.5F dilator, 94cm dilator length, 91 lumen length, 180cm guidewire length
Catalog Number
408309
Brand Name
N/A
Version/Model Number
N/A
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
K123334
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
ff6ed760-69b5-4c85-b301-6bae5fdaa4a4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 304 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
| U | Unclassified | 12 |