Duns Number:071595540
Device Description: ANCHORPORT 5MM SINGLE INCISION LAPAROSCOPY KIT, 75MM LENGTH, QTY 6
Catalog Number
AP5-75-SILK
Brand Name
ANCHORPORT
Version/Model Number
AP5-75-SILK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 06, 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
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
K100180,K100180,K100180
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
4415925c-352a-4d33-ab7a-ddd3755778aa
Public Version Date
June 07, 2022
Public Version Number
6
DI Record Publish Date
February 23, 2018
Package DI Number
20845854046415
Quantity per Package
6
Contains DI Package
10845854046418
Package Discontinue Date
June 06, 2022
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 |