Duns Number:832696038
Device Description: SPLANCHNIC RIBBON SWIVEL BLADE FOR USE WITH THE HORSESHOE RETRACTOR SET, 2" X 6" (5.1CM X SPLANCHNIC RIBBON SWIVEL BLADE FOR USE WITH THE HORSESHOE RETRACTOR SET, 2" X 6" (5.1CM X 15.2CM) ALUMINUM
Catalog Number
SU3280-504
Brand Name
V. Mueller
Version/Model Number
SU3280-504
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
44573de8-09c7-4f8c-90b8-c18d33875ee4
Public Version Date
May 10, 2021
Public Version Number
4
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 |