Duns Number:200564891
Device Description: 6 in X 5 yards premium elastic bandage with removable clips. Sterile
Catalog Number
DUP71506LF
Brand Name
PrimaCare®
Version/Model Number
71506LF
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
cacb8960-afe9-4ea5-bc2a-6b980f7943f3
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
March 06, 2019
Package DI Number
00809958079324
Quantity per Package
24
Contains DI Package
00809958079317
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 | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 42 |