Duns Number:058614483
Device Description: Blunt Trocar with Threaded Anchor
Catalog Number
BPT12STS
Brand Name
VersaOne
Version/Model Number
BPT12STS
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
K142547,K142547
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
64c7b3af-b822-41ac-84d8-25117e1f332c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 17, 2018
Package DI Number
30884521621057
Quantity per Package
3
Contains DI Package
20884521621050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |