Duns Number:070556204
Device Description: Curaplex Select Laryngoscope Blade, Miller 00, LED, Disposable 20ea/bx
Catalog Number
2145-13500
Brand Name
Curaplex
Version/Model Number
2145-13500
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCW
Product Code Name
LARYNGOSCOPE, RIGID
Public Device Record Key
9b415bc8-d0ba-428a-ac1b-cd16c3b5934b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 20, 2017
Package DI Number
00817617024103
Quantity per Package
20
Contains DI Package
00817617024097
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| 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 |