Duns Number:260445203
Device Description: Microlap - 200mm insert with 2 movable Fenestrated jaws length 10mm
Catalog Number
LIL-IP-F10-20
Brand Name
Microlap - 200mm insert with 2 movable Fenestrated jaws length 10mm
Version/Model Number
LIL-IP-F10-20
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K140101
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
081a29ab-9c92-4229-bf66-b6d35946fa1b
Public Version Date
July 08, 2019
Public Version Number
1
DI Record Publish Date
June 28, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 198 |