Duns Number:041674552
Device Description: Triangular Bandage (non-woven)
Catalog Number
Not Applicable
Brand Name
MedSource Triangle Bandage
Version/Model Number
MS-11050
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILI
Product Code Name
Sling, Arm
Public Device Record Key
d2c85bbd-1713-42d8-9d85-6db62ff44d2b
Public Version Date
May 05, 2021
Public Version Number
1
DI Record Publish Date
April 27, 2021
Package DI Number
00816703024485
Quantity per Package
240
Contains DI Package
00816703024478
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 | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |