Duns Number:063865158
Device Description: Medi-Band Seamless Tubular Band Precut - Size 12 IN x 16 IN
Catalog Number
MBF261216
Brand Name
Medi-Band
Version/Model Number
MBF261216
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
ISR
Product Code Name
Band Or Belt, Pelvic Support
Public Device Record Key
32c928ef-f1eb-46c9-a46a-246a479fddaf
Public Version Date
October 07, 2019
Public Version Number
2
DI Record Publish Date
July 30, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |