Duns Number:023904428
Device Description: GLOVE, LATEX CODEBLUE 12" 14 ML PF BLU, M
Catalog Number
-
Brand Name
Cypress
Version/Model Number
23-34
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYY
Product Code Name
Latex Patient Examination Glove
Public Device Record Key
d45570fb-1df9-4298-a43c-33b4eb908820
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
May 26, 2020
Package DI Number
00815555024711
Quantity per Package
10
Contains DI Package
00815555024674
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |