Duns Number:058614483
Device Description: Insufflation Needle
Catalog Number
-
Brand Name
VersaStep
Version/Model Number
VS150000
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
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
K012539,K012539
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
3d22952c-a928-4f82-a747-b14a56fe5d1b
Public Version Date
March 30, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10884521093614
Quantity per Package
12
Contains DI Package
20884521093611
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |