Duns Number:079290879
Device Description: The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
Catalog Number
91010
Brand Name
PICC WAND
Version/Model Number
4Fr
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
K111138,K111138,K111138
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
20442f07-5d76-4af4-b978-3d512ba78203
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
30859821006132
Quantity per Package
18
Contains DI Package
20859821006135
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Overpack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |