Duns Number:005473608
Device Description: EXA’lence™ Regular Set 48mL Cartridge Extra Light Body (Yellow), 4 x cartridges, 12 x mixi EXA’lence™ Regular Set 48mL Cartridge Extra Light Body (Yellow), 4 x cartridges, 12 x mixing tips
Catalog Number
137224
Brand Name
EXAlence™
Version/Model Number
137224
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
K041398,K041398
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
47774bd1-5734-4a71-a814-8b035c0b3d18
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 2022
Package DI Number
20386040013359
Quantity per Package
8
Contains DI Package
10386040013352
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |