Duns Number:005052360
Catalog Number
8617L
Brand Name
Diversamed
Version/Model Number
8617L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K131832
Product Code
LYZ
Product Code Name
Vinyl Patient Examination Glove
Public Device Record Key
7ac26d2f-b587-4c19-be52-10ea6be014bc
Public Version Date
March 24, 2020
Public Version Number
1
DI Record Publish Date
March 16, 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 | 48 |