Duns Number:081840873
Device Description: Adaptable Arm, Leg Positioner, Disposable Kit, Qty 5
Catalog Number
-
Brand Name
DJO SURGICAL
Version/Model Number
803-33-105
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"
Yes
For Single-Use
Yes
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
IPM
Product Code Name
COVER, LIMB
Public Device Record Key
36c27fc3-4f2e-4b50-a2ed-18bfae030ef5
Public Version Date
August 27, 2021
Public Version Number
1
DI Record Publish Date
August 19, 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 | 784 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1030 |
| 3 | A medical device with high risk that requires premarket approval | 8 |