Duns Number:023904428
Device Description: GLOVE, VINYL TRILON 2000 PF SYNTHETIC, L
Catalog Number
-
Brand Name
Cypress
Version/Model Number
25-970
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYZ
Product Code Name
Vinyl Patient Examination Glove
Public Device Record Key
f0c19a5d-0f70-47c9-8910-7c986fac2ca7
Public Version Date
May 28, 2020
Public Version Number
1
DI Record Publish Date
May 20, 2020
Package DI Number
20815555020588
Quantity per Package
10
Contains DI Package
10815555020581
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 |