Duns Number:091301184
Device Description: For supporting the vagina during laparoscopic vaginal procedures. 45 mm width, inserted en For supporting the vagina during laparoscopic vaginal procedures. 45 mm width, inserted end.
Catalog Number
-
Brand Name
VCM 45
Version/Model Number
VCM-45
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
HDL
Product Code Name
Retractor, Vaginal
Public Device Record Key
24b899bc-c79f-4a56-9ecf-301e3a891bbe
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 26, 2017
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |