Duns Number:878427491
Device Description: Lombardi Leg Positioner Footpiece Only
Catalog Number
2622-FP
Brand Name
Innomed, Inc.
Version/Model Number
2622-FP
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KIL
Product Code Name
Positioner, Socket
Public Device Record Key
e59e3d4e-60a0-4745-942e-9488c6951f8b
Public Version Date
August 10, 2021
Public Version Number
1
DI Record Publish Date
August 02, 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 | 2683 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |