Duns Number:354818510
Device Description: Standing mobile lift system sling/harness
Catalog Number
-
Brand Name
Solo SupportVest™, Mod. 911
Version/Model Number
35911916
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
5b290ea4-e9ce-4672-ad2f-a180af14e722
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
March 22, 2021
Package DI Number
00887761983960
Quantity per Package
20
Contains DI Package
00887761979581
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 267 |