Duns Number:061310132
Device Description: MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" WITH STERIPICK INCLUDED WIT MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 15G X 1" WITH STERIPICK INCLUDED WITH TWIN PACK BH-2005PE
Catalog Number
-
Brand Name
Medisystems Button Hole Needle Set with SteriPick
Version/Model Number
BH-7005PE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 24, 2020
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
FIE
Product Code Name
Needle, Fistula
Public Device Record Key
056a276c-e32d-4ced-a303-b65dc272ea8e
Public Version Date
June 26, 2020
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 167 |