Duns Number:315018218
Device Description: UNIVATION XF FEM.TRIAL/PREP.GUIDE F5 LM
Catalog Number
NM618R
Brand Name
UNIVATION XF
Version/Model Number
NM618R
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HTZ
Product Code Name
INSTRUMENT, CUTTING, ORTHOPEDIC
Public Device Record Key
e74708ba-968b-4622-8120-0beb9167ba95
Public Version Date
May 04, 2020
Public Version Number
1
DI Record Publish Date
April 24, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |