Duns Number:354818510
Device Description: Patient lifting system stretcher
Catalog Number
-
Brand Name
Solo Octo LiftSheet™
Version/Model Number
3683905
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
cf8eb606-655f-4099-8fdd-d45aa6c0a340
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
March 22, 2021
Package DI Number
10887761984209
Quantity per Package
40
Contains DI Package
00887761984202
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 |