Duns Number:896844250
Device Description: Laparoscopy wound closure system kit consists of:05391529640002; neoClose AnchorGuide 5/12 Laparoscopy wound closure system kit consists of:05391529640002; neoClose AnchorGuide 5/12 & 8/15 US; Model Number NCA515-U; Qty 10 and05391529640019; neoClose AutoAnchor x2 PAck US; Model Number NCA2-U; Qty 10
Catalog Number
-
Brand Name
neoClose AnchorGuide Regular Port Closure Kit US
Version/Model Number
NCAGR-U
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
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
K142903,K142903
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
f07c5a2b-33ef-4d27-89e9-33c91056d3f1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 11, 2016
Package DI Number
05391529640033
Quantity per Package
4
Contains DI Package
05391529640026
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |