Duns Number:283658730
Device Description: Amputationsling (2 legs) Daylite Fabric ; hygiene opening; Custom Made
Catalog Number
-
Brand Name
Handi-Move Sling
Version/Model Number
3545 90000001
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
a929f0a6-aadb-40c2-810c-47efc375f2d9
Public Version Date
September 16, 2020
Public Version Number
1
DI Record Publish Date
September 08, 2020
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 | 260 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |