Duns Number:008999906
Device Description: The AUTO-FILL Syringe Kit is indicated for introduction of dilute lidocaine solutions into The AUTO-FILL Syringe Kit is indicated for introduction of dilute lidocaine solutions into the subcutaneous tissue for the purposes of local anesthesia.
Catalog Number
-
Brand Name
Auto-Fill® syringe kit
Version/Model Number
7600
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
1fceda93-0259-45f4-af00-0c5e5859f1fd
Public Version Date
November 11, 2019
Public Version Number
4
DI Record Publish Date
September 06, 2016
Package DI Number
M20676001
Quantity per Package
10
Contains DI Package
M20676000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |