Duns Number:256880576
Device Description: Ritmed Tubular Mesh Bandage Roll - Length: 25 yd - Size: 6 (Large Head, Shoulder and Thigh Ritmed Tubular Mesh Bandage Roll - Length: 25 yd - Size: 6 (Large Head, Shoulder and Thigh)
Catalog Number
51416-LF
Brand Name
Ritmed
Version/Model Number
51416-LF
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
FQM
Product Code Name
BANDAGE, ELASTIC
Public Device Record Key
19fdf3fb-ec3a-4282-98ae-2ce36783a7d7
Public Version Date
January 06, 2022
Public Version Number
3
DI Record Publish Date
January 13, 2019
Package DI Number
20686864048729
Quantity per Package
32
Contains DI Package
10686864048722
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |