Duns Number:119193803
Device Description: With new, high-visibility target graphics, PRACTIshield slips onto any needle sheath, crea With new, high-visibility target graphics, PRACTIshield slips onto any needle sheath, creating an effective prop for easier one-handed resheathing. Helps to remind and reinforce a safe technique. Puncture-resistant die-cut cardboard. 100 single-use shields per pack.
Catalog Number
70-4970
Brand Name
PRACTIshield Sheath Props
Version/Model Number
70-4970
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZM
Product Code Name
Needle, Dental
Public Device Record Key
9ad9879e-4566-47a5-bf0f-61df0e42f117
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |