Duns Number:023904428
Device Description: MODULON POWDER FREE LATEX GLOVES TEXTURED NON-STERILE NATURAL OFF WHITE
Catalog Number
-
Brand Name
McKesson
Version/Model Number
14-020 M
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)
Yes
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
083d970a-fac2-4dd8-adfb-bb87d1e51d3c
Public Version Date
July 03, 2020
Public Version Number
1
DI Record Publish Date
June 25, 2020
Package DI Number
00612479150034
Quantity per Package
10
Contains DI Package
00612479150027
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 |