Duns Number:430899318
Device Description: The Needlestick Safety system is designed for safely recapping needles. The device consist The Needlestick Safety system is designed for safely recapping needles. The device consists of a disk, filled with 100 micro rubber caps, suitable for recapping needles after utilisation, for a safe disposal.
Catalog Number
20200707
Brand Name
Orabloc - needle stick safety system
Version/Model Number
20200707
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
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
b4fed59d-8f88-489f-82bc-50b277d98bc4
Public Version Date
November 09, 2020
Public Version Number
1
DI Record Publish Date
October 30, 2020
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. | 3 |