Duns Number:006261481
Device Description: SHEATH SENSH2628W Sentrant Hydr EtO eIFU
Catalog Number
-
Brand Name
Sentrant™
Version/Model Number
SENSH2628W
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
K171866
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
8612b2cb-fbc8-4372-aa74-9e9c45f7a256
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 29, 2018
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |