Duns Number:006261481
Device Description: INTRODUCER 6208-S5 SPLITTABLE 8FR 5PK
Catalog Number
-
Brand Name
NA
Version/Model Number
6208-S5
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
K911236,K951313,K911236,K951313
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
0f842301-a6dd-4887-a060-b30de7e3e027
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
January 03, 2017
Package DI Number
10613994391565
Quantity per Package
5
Contains DI Package
00613994391568
Package Discontinue Date
-
Package Status
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 |