Duns Number:041674552
Device Description: Extrication Collar, Pediatric
Catalog Number
Not Applicable
Brand Name
MedSource Extrication Collar
Version/Model Number
MS-EX200
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
cf62ec88-38fa-4d5b-b788-81c9c91bb58c
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
July 30, 2021
Package DI Number
00840155403819
Quantity per Package
50
Contains DI Package
00840155403802
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 498 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |