Duns Number:071595540
Device Description: ANCHORPORT 5/100MM INS CANNULA
Catalog Number
APCi5-100
Brand Name
ANCHORPORT
Version/Model Number
APCi5-100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 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"
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
3b2826be-420f-45cf-a9a5-e20812e44b92
Public Version Date
October 01, 2020
Public Version Number
1
DI Record Publish Date
September 23, 2020
Package DI Number
20845854046446
Quantity per Package
12
Contains DI Package
10845854046449
Package Discontinue Date
June 22, 2022
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 |