Duns Number:832696038
Device Description: RAVITCH PYLORIC STENOSIS SPREADER, SMALL LIP ON BLADE BLADES OPEN AS HANDLES CLOSE OVERALL RAVITCH PYLORIC STENOSIS SPREADER, SMALL LIP ON BLADE BLADES OPEN AS HANDLES CLOSE OVERALL LENGTH 5-3/4" (14.6CM)
Catalog Number
SU8085
Brand Name
V. Mueller
Version/Model Number
SU8085
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
GAD
Product Code Name
RETRACTOR
Public Device Record Key
b5a63262-11fe-4024-8a58-1875264db4b0
Public Version Date
April 03, 2019
Public Version Number
2
DI Record Publish Date
September 18, 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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |