Duns Number:084042331
Device Description: The ManaEZ sling is a convenient, comfortable, and simple way to immobilize the shoulder a The ManaEZ sling is a convenient, comfortable, and simple way to immobilize the shoulder and elbow. The over the shoulder strap is made out of comfortable material for the optimal patient experience. For non-surgical or post-op support and immobilization of the shoulder. Simple and comfortable
Catalog Number
EZSL01S
Brand Name
ManaMed
Version/Model Number
ManaEZ Sling Small
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILI
Product Code Name
Sling, Arm
Public Device Record Key
33140acf-13d6-4e4c-a40f-5af1ef6d7592
Public Version Date
June 28, 2022
Public Version Number
1
DI Record Publish Date
June 20, 2022
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 | 128 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |