Duns Number:010016319
Device Description: Superflex Protective Gloves 12" 0.5mm
Catalog Number
-
Brand Name
Wolf X-Ray Protective Gloves
Version/Model Number
12419
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
-
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
IWP
Product Code Name
Radiographic Protective Glove
Public Device Record Key
26df7ddf-2c5e-4867-92b1-4112b93cd4ae
Public Version Date
August 11, 2020
Public Version Number
1
DI Record Publish Date
August 03, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3215 |