Duns Number:080061451
Device Description: HEPRO.US Nitrile Standard Class Series 400Disposable Nitrile Gloves Series 400, Ambidextro HEPRO.US Nitrile Standard Class Series 400Disposable Nitrile Gloves Series 400, Ambidextrous, Color Blue, Size Medium 1 Box 100pcs
Catalog Number
-
Brand Name
HEPRO.US Nitrile Standard Class Series 400 Medium
Version/Model Number
BX - 400 Nitrile Medium
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
81424534-f4d5-4bf1-9b8a-f71e82ec03f9
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
June 21, 2017
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |