Duns Number:063997360
Device Description: LDR Adhesive Waterproof Tape 0.5 in x 10 yds 1 roll
Catalog Number
5734314
Brand Name
LEADER
Version/Model Number
5734314
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
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
7be63082-9106-4df6-9156-7d254b3ce3d7
Public Version Date
January 14, 2022
Public Version Number
1
DI Record Publish Date
January 06, 2022
Package DI Number
30096295141246
Quantity per Package
6
Contains DI Package
00096295141245
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |