Duns Number:276593071
Device Description: RING 7783-12 2PK FOR SYRINGE CHOUARD
Catalog Number
7783-12
Brand Name
MicroFrance®
Version/Model Number
7783-12
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
KCP
Product Code Name
SYRINGE, ENT
Public Device Record Key
468d4e13-7526-41bc-8654-580314c08645
Public Version Date
December 21, 2020
Public Version Number
3
DI Record Publish Date
September 01, 2017
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 | 1433 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 879 |