Duns Number:514870547
Device Description: The EndoLift is intended to retract and shift internal organs during minimally invasive su The EndoLift is intended to retract and shift internal organs during minimally invasive surgery. The EndoLift is an internally anchored, hands-free retracting device, which eliminates the need for a hand held retractor during surgery.
Catalog Number
EL000A5
Brand Name
EndoLift
Version/Model Number
EL000A
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
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
-
Product Code
GAD
Product Code Name
Retractor
Public Device Record Key
e853ba74-315e-494b-82fc-1e333686a4f7
Public Version Date
July 01, 2021
Public Version Number
1
DI Record Publish Date
June 23, 2021
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 | 2 |