Duns Number:006261481
Device Description: ACCESSORY 6207S5S 5PK SC W/7F DILATOR
Catalog Number
-
Brand Name
NA
Version/Model Number
6207S5S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 02, 2018
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
d974b46b-3975-459a-8d61-3e789da5e597
Public Version Date
June 07, 2019
Public Version Number
5
DI Record Publish Date
January 03, 2017
Package DI Number
10721902577625
Quantity per Package
5
Contains DI Package
00721902577628
Package Discontinue Date
May 02, 2018
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 |