Duns Number:101835833
Device Description: Steerable Guiding Sheath, 12F
Catalog Number
51GS012
Brand Name
Occlutech® Steerable Guiding Sheath
Version/Model Number
51GS012
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 11, 2019
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
K120459
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
c52b4f71-3cf8-4a37-9f04-a4d1e91588ba
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
November 21, 2017
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. | 592 |
3 | A medical device with high risk that requires premarket approval | 16 |