Duns Number:058614483
Device Description: Short Radially Expandable Sleeve
Catalog Number
-
Brand Name
VersaStep
Version/Model Number
VSR100800
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 06, 2021
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
b522ce89-69ba-43e1-958d-c641f40f585e
Public Version Date
March 30, 2022
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
10884521084162
Quantity per Package
6
Contains DI Package
20884521084169
Package Discontinue Date
October 06, 2021
Package Status
Not 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 |