Duns Number:817435655
Device Description: Senhance Manipulator Drape 3-PK X9007636
Catalog Number
X9007636
Brand Name
TransEnterix
Version/Model Number
X9007636
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"
Yes
For Single-Use
Yes
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
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
855f00b7-b1cc-4ece-9222-0fbf86bfc00a
Public Version Date
March 29, 2021
Public Version Number
1
DI Record Publish Date
March 19, 2021
Package DI Number
17466532979021
Quantity per Package
10
Contains DI Package
07466532979024
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |