Duns Number:790937150
Device Description: SLING, COMFORT, DISP, LG
Catalog Number
NA25613
Brand Name
Slings
Version/Model Number
NA25613
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
FSA
Product Code Name
Lift, Patient, Non-Ac-Powered
Public Device Record Key
0ac984ab-e727-4197-ac69-344392257af2
Public Version Date
January 31, 2022
Public Version Number
1
DI Record Publish Date
January 23, 2022
Package DI Number
20810055882100
Quantity per Package
10
Contains DI Package
00810055882106
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 164 |
2 | A medical device with a moderate to high risk that requires special controls. | 131 |