Duns Number:063997360
Device Description: LDR First Aid Kit 70 pieces
Catalog Number
5459466
Brand Name
LEADER
Version/Model Number
5459466
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRR
Product Code Name
First Aid Kit with drug
Public Device Record Key
7aba6cbe-0192-4d31-b288-229fbc382233
Public Version Date
July 02, 2021
Public Version Number
2
DI Record Publish Date
June 27, 2019
Package DI Number
50096295135386
Quantity per Package
36
Contains DI Package
00096295135381
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 | 23 |
2 | A medical device with a moderate to high risk that requires special controls. | 39 |