Duns Number:071595540
Device Description: ANCHORPORT 5MM TROCAR WITH BLADELESS OPTICAL TIP OBTURATOR AND CANNULA WITH INSUFFLATION P ANCHORPORT 5MM TROCAR WITH BLADELESS OPTICAL TIP OBTURATOR AND CANNULA WITH INSUFFLATION PORT, 100MM LENGTH, QTY 6
Catalog Number
AP5-100
Brand Name
ANCHORPORT
Version/Model Number
AP5-100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 22, 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
-
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
7e204098-2055-4cf4-b624-31e27fe95131
Public Version Date
March 23, 2021
Public Version Number
5
DI Record Publish Date
February 23, 2018
Package DI Number
20845854046392
Quantity per Package
6
Contains DI Package
10845854046395
Package Discontinue Date
March 22, 2021
Package Status
Not in Commercial Distribution
Package Type
BOX
| 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 |