Duns Number:960754430
Device Description: ***DISC*IGLI BUSINESS SILVER M-E39/40 M5
Catalog Number
-
Brand Name
MEDI
Version/Model Number
PJH4139
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 20, 2020
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IQI
Product Code Name
ORTHOSIS, LIMB BRACE
Public Device Record Key
b53e24a5-bb42-470c-85eb-693881a1b902
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
January 02, 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 | 2971 |
2 | A medical device with a moderate to high risk that requires special controls. | 9550 |