Duns Number:071595540
Device Description: ANCHORPORT 5MM CANNULA WITH INSUFFLATION PORT, 135MM LONG
Catalog Number
APCi5-135
Brand Name
ANCHORPORT
Version/Model Number
APCi5-135
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 22, 2017
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"
Yes
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
73a3ee26-41aa-483a-884f-dea85cdc80c0
Public Version Date
January 09, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20851885004553
Quantity per Package
12
Contains DI Package
10851885004556
Package Discontinue Date
August 22, 2017
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 | 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 |