Duns Number:878070325
Device Description: FSSA PPE Kit; Each Kit Includes Large Nitrile Exam Glove (10), and Large Alcohol Prep Pad FSSA PPE Kit; Each Kit Includes Large Nitrile Exam Glove (10), and Large Alcohol Prep Pad (5).
Catalog Number
10-90801
Brand Name
Bosma Enterprises
Version/Model Number
10-90801
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
-
Product Code
PXC
Product Code Name
Personal Protection Kit
Public Device Record Key
5f53de55-b975-46e9-9b08-d3e840ed03b3
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 02, 2021
Package DI Number
10818634025002
Quantity per Package
10
Contains DI Package
00818634025005
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 | 72 |