Duns Number:005473608
Device Description: G-aenial Universal Injectable B2, Dispensing Tip Needle (10), Dispensing Tip Long Needle ( G-aenial Universal Injectable B2, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10), Light Protective Cap (2)
Catalog Number
012370
Brand Name
G-aenial™
Version/Model Number
012370
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
K173500,K173500
Product Code
EBF
Product Code Name
Material, tooth shade, resin
Public Device Record Key
27cf1f8d-14d8-4693-89ea-32992654e6e6
Public Version Date
August 15, 2022
Public Version Number
1
DI Record Publish Date
August 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |