Duns Number:008124539
Device Description: Elastic Bandage with Self-Closure, 6"x5yds
Catalog Number
-
Brand Name
Elastic Bandage with Self-Closure
Version/Model Number
3661
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
b2d97110-b7fd-4214-9b1b-3019320c5928
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
September 01, 2021
Package DI Number
00616784366135
Quantity per Package
5
Contains DI Package
00616784366128
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |