Duns Number:041674552
Device Description: School Health fanny pack, Navy
Catalog Number
Not Applicable
Brand Name
MedSource Packed Fanny Pack
Version/Model Number
SH-B1215
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
-
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
-
Product Code Name
-
Public Device Record Key
f70bdaab-ce8d-4e7b-b01d-f34162ae95fe
Public Version Date
September 02, 2021
Public Version Number
1
DI Record Publish Date
August 25, 2021
Package DI Number
00816703024027
Quantity per Package
50
Contains DI Package
00816703024010
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 | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |