Duns Number:070556204
Device Description: Curaplex PPE Kit- Basic, Mask w/Visor
Catalog Number
670201-KIT
Brand Name
Curaplex
Version/Model Number
670201-KIT
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
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
LYU
Product Code Name
ACCESSORY, SURGICAL APPAREL
Public Device Record Key
d5aca3b6-589d-4735-b27d-c7cc2841cf67
Public Version Date
August 16, 2022
Public Version Number
2
DI Record Publish Date
September 30, 2021
Package DI Number
00810094571368
Quantity per Package
50
Contains DI Package
00812277036695
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 |