Duns Number:006261481
Device Description: STYLET KIT 6048-52 GLBL STRGHT BLUNT
Catalog Number
-
Brand Name
NA
Version/Model Number
6048-52
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 15, 2020
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
-
Product Code
DRB
Product Code Name
STYLET, CATHETER
Public Device Record Key
633b5e3f-6ae3-4773-85b6-7af022b862e4
Public Version Date
May 16, 2022
Public Version Number
3
DI Record Publish Date
April 04, 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 | 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 |