Duns Number:082745034
Catalog Number
-
Brand Name
ALPHA
Version/Model Number
IS-6040MD (S)
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110981,K110981
Product Code
FMC
Product Code Name
Patient Examination Glove
Public Device Record Key
c2fcd162-ae26-44b7-bcb3-f972df0dc175
Public Version Date
October 11, 2022
Public Version Number
2
DI Record Publish Date
July 31, 2022
Package DI Number
00810007199900
Quantity per Package
10
Contains DI Package
00810007199856
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 | 1 |