Duns Number:896844250
Device Description: Laparoscopy wound closure system kit consists of: 05391529640002; neoClose AnchorGuide 5/1 Laparoscopy wound closure system kit consists of: 05391529640002; neoClose AnchorGuide 5/12 & 8/15 US; Model Number NCA5/15-U; Qty 10 and 05391529640057; neoClose AutoAnchor x4 Pack US; Model Number NCA4-U; Qty 10.
Catalog Number
-
Brand Name
neoClose AnchorGuide Regular Port Closure Kit x2 US
Version/Model Number
NCAGRX2-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
79394e83-5c94-46b9-a85e-0500cad93085
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 11, 2016
Package DI Number
05391529640095
Quantity per Package
4
Contains DI Package
05391529640088
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 |