Duns Number:071595540
Device Description: 5mm, Long, Pediatric Open Laparoscopic Adapter and Blunt lip Trocar for Entry® II Cannula, 5mm, Long, Pediatric Open Laparoscopic Adapter and Blunt lip Trocar for Entry® II Cannula, Reusable
Catalog Number
CD1402
Brand Name
CORE DYNAMICS
Version/Model Number
CD1402
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 28, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K932020,K932020
Product Code
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
66f24101-0394-40b2-a53a-62998c9aa960
Public Version Date
March 29, 2022
Public Version Number
4
DI Record Publish Date
September 24, 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |