Duns Number:809699023
Device Description: NEEDLE 18G X 15 CHIBA STYLET ECHO TIP
Catalog Number
-
Brand Name
ENVI
Version/Model Number
35-519
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
K170775
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
4646225c-9922-4542-a3d6-206cc63fa46e
Public Version Date
August 16, 2021
Public Version Number
6
DI Record Publish Date
August 07, 2017
Package DI Number
H965355191
Quantity per Package
5
Contains DI Package
H965355190
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 | 71 |
2 | A medical device with a moderate to high risk that requires special controls. | 1641 |