Duns Number:071595540
Device Description: Fascia Anchor Adapter Seal Replacement
Catalog Number
G3-R12GK
Brand Name
ENTRIPORT
Version/Model Number
G3-R12GK
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K142464,K142464,K142464,K142464
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
a7cd9fc5-d3c1-4ec0-bc5f-8c327f188a45
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10653405082460
Quantity per Package
10
Contains DI Package
20653405082467
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
POUCH
| 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 |