Duns Number:300207996
Device Description: Short-term patient stabilization device
Catalog Number
38037
Brand Name
iFIX
Version/Model Number
Slot Adapter 2.0/30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
FMQ
Product Code Name
Restraint, Protective
Public Device Record Key
18fce657-21b8-4705-91d8-5fbca16de861
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
March 31, 2019
Package DI Number
49010279000211
Quantity per Package
2
Contains DI Package
29010279000217
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |