Duns Number:021717889
Device Description: Radiation Reduction Examination Gloves
Catalog Number
-
Brand Name
ESP™
Version/Model Number
M001201100
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)
Yes
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
IWP
Product Code Name
Radiographic protective Glove
Public Device Record Key
dbec319c-63cb-4345-88bd-6a13ab41f47e
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
08714729175605
Quantity per Package
3
Contains DI Package
08714729735151
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |