Duns Number:315304071
Device Description: TROCAR TIP DULL SZ 24MM with central channel for primary insufflation, for single port tr TROCAR TIP DULL SZ 24MM with central channel for primary insufflation, for single port trocar sleeve 885030, reusable
Catalog Number
885031
Brand Name
KEYPORT
Version/Model Number
885031
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
OTJ
Product Code Name
Laparoscopic single port access device
Public Device Record Key
9f3fec44-f594-467f-a622-05a695d41362
Public Version Date
January 31, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |