Duns Number:030479000
Device Description: PERFECTO LIGHT BODY SHM YELLOW FAST SET - 50 mL CARTRIDGE
Catalog Number
DW63
Brand Name
PERFECTO
Version/Model Number
DW63
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
71237cfe-aacf-4309-8b10-dd3270cf1efe
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 23, 2018
Package DI Number
10818524020254
Quantity per Package
2
Contains DI Package
00818524020257
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
KIT
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |