Duns Number:220683901
Device Description: A sterile, singe use, acrylic dome shaped device with a port for attachment of the suction A sterile, singe use, acrylic dome shaped device with a port for attachment of the suction system and septum for the insertion of a Veress needle. It assists in the blind passage of a 14G Veress needle to establish a pneumoperitoneum prior to laparoscopic procedures. The device is centered over the umbilicus, a suction hose is attached to the suction port and negative pressure applied. The abdomen rises, allowing the Veress needle to be inserted into the created space. Inert gas is delivered to replace the negative pressure.
Catalog Number
LC2-STD
Brand Name
Lapcap2
Version/Model Number
LC2-STD
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
K070651,K070651,K070651
Product Code
HIF
Product Code Name
Insufflator, Laparoscopic
Public Device Record Key
c1406ff5-3f87-47d8-b33e-ed68b86c6c99
Public Version Date
March 04, 2019
Public Version Number
4
DI Record Publish Date
June 08, 2016
Package DI Number
15060484670009
Quantity per Package
10
Contains DI Package
05060484670002
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Cardboard