Duns Number:960754430
Device Description: 8-15 SHEER&SOFT CALF CT NATURAL XL
Catalog Number
-
Brand Name
MEDI
Version/Model Number
02404
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQL
Product Code Name
STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)
Public Device Record Key
3fda7188-e4a7-467e-ba0b-5185b0e3b3bd
Public Version Date
July 07, 2020
Public Version Number
4
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 |