Duns Number:006261481
Device Description: INTRO 6209-D1 ACCESSORY INTRO DC 9F
Catalog Number
-
Brand Name
NA
Version/Model Number
6209-D1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 17, 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
K911236,K951313
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
36ae8e66-79f6-41f9-8f1d-9e088ba22f3d
Public Version Date
March 16, 2021
Public Version Number
5
DI Record Publish Date
January 03, 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 |
|---|---|---|
| 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 |