Duns Number:025460908
Device Description: GLOVE,IND,LATEX,PF,STEEL SPLSH,30CT,L-XL
Catalog Number
VEN6025
Brand Name
Venom
Version/Model Number
VEN6025
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
e9e08287-4c09-434f-9093-5ef375c8ab98
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 11, 2022
Package DI Number
30888277300402
Quantity per Package
4
Contains DI Package
00888277300401
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
RETAIL INNER PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |