Duns Number:038000253
Device Description: 3F (1.0MM ID) X 5CM PTFE3F (1.0M TEARAWAYTEARAWAY
Catalog Number
DMR190306
Brand Name
SUPER SHEATH 2.1SUPER SHEATH 2.1
Version/Model Number
DMR190306
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"
Yes
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
bc5cdea1-0929-4972-8100-ceb06b812a70
Public Version Date
August 19, 2019
Public Version Number
1
DI Record Publish Date
August 09, 2019
Package DI Number
50884908145439
Quantity per Package
10
Contains DI Package
00884908145434
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |