Duns Number:276593071
Device Description: RETRACTOR CP21A-3 140MM 3 PRONGS BLUNT
Catalog Number
CP21A-3
Brand Name
MicroFrance®
Version/Model Number
CP21A-3
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
GAD
Product Code Name
RETRACTOR
Public Device Record Key
38996b42-0381-4f32-afa8-b0da9ee466c9
Public Version Date
October 04, 2022
Public Version Number
4
DI Record Publish Date
June 02, 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 |