Duns Number:831375089
Device Description: Cohesive Bandage, Sterile, 3" x 5" Stretched, Tan, Not made with Natural Rubber Latex
Catalog Number
8953
Brand Name
PremierPro
Version/Model Number
8953
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
42bc8f5c-24b0-4cc5-8465-c7b0f3b5c420
Public Version Date
May 25, 2022
Public Version Number
2
DI Record Publish Date
August 29, 2020
Package DI Number
10818566016727
Quantity per Package
24
Contains DI Package
00818566016720
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |