Duns Number:004324596
Device Description: PATIENT LT KEY STLE STRRP ASSY SHRT w/ HDW
Catalog Number
-
Brand Name
UMF Medical
Version/Model Number
R1-2799
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EYD
Product Code Name
Stirrups
Public Device Record Key
340f1311-e4e3-4dda-bcb8-c0c7fb1bd7e9
Public Version Date
October 26, 2018
Public Version Number
1
DI Record Publish Date
September 25, 2018
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 | 155 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |