Duns Number:121464288
Device Description: Surgical Knot Pushers 23-38034 (MICS Shovel Retractor, Small, Blade Width 3/8",Blade Depth Surgical Knot Pushers 23-38034 (MICS Shovel Retractor, Small, Blade Width 3/8",Blade Depth 3/4")
Catalog Number
-
Brand Name
Vitalitec Shovel Retractors
Version/Model Number
23-38034
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
DWS
Product Code Name
Instruments, Surgical, Cardiovascular
Public Device Record Key
17f607f1-6f66-40f1-815b-93584b15a126
Public Version Date
January 14, 2019
Public Version Number
1
DI Record Publish Date
December 13, 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 | 163 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 72 |