Duns Number:006261481
Device Description: STYLET 628275 US DS KNOB ST
Catalog Number
-
Brand Name
NA
Version/Model Number
628275
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 11, 2021
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
K010906,K010906
Product Code
DRB
Product Code Name
STYLET, CATHETER
Public Device Record Key
3d92cca3-819d-4048-97f5-2b76dad361d6
Public Version Date
May 02, 2022
Public Version Number
4
DI Record Publish Date
April 01, 2016
Package DI Number
20613994618683
Quantity per Package
5
Contains DI Package
00613994618689
Package Discontinue Date
November 11, 2021
Package Status
Not in Commercial Distribution
Package Type
PK
| 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 |