Duns Number:070556204
Device Description: Curaplex Patient Mover
Catalog Number
3246-12345
Brand Name
Curaplex
Version/Model Number
3246-12345
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMR
Product Code Name
DEVICE, TRANSFER, PATIENT, MANUAL
Public Device Record Key
5968113f-54c4-4afd-b665-4c2ba2ca87ea
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 04, 2017
Package DI Number
00817617026480
Quantity per Package
10
Contains DI Package
00817617025971
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |