Duns Number:127609332
Device Description: Pediatric Yellow Pelvic Binder. Soft goods medical brace for stabilization of fractured pe Pediatric Yellow Pelvic Binder. Soft goods medical brace for stabilization of fractured pelvis used by physicians in emergency room and paramedics in the pre-hospital environment.
Catalog Number
PED4x30
Brand Name
Pelvic Binder
Version/Model Number
PED4x30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
MRI
Product Code Name
Orthosis, Truncal/Orthosis, Limb
Public Device Record Key
ed2a6cc7-f1bf-4e7a-8f88-eae83c64733f
Public Version Date
January 04, 2022
Public Version Number
1
DI Record Publish Date
December 27, 2021
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 | 2 |