Duns Number:121622872
Device Description: STIFFENING CANNULA, 4CM F/GSC-4CMPN 60001-02M
Catalog Number
SC-4CM
Brand Name
STIFFENING CANNULA, 4CM F/G
Version/Model Number
4CM
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"
Yes
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
K845038,K845038,K845038
Product Code
GDF
Product Code Name
Guide, Needle, Surgical
Public Device Record Key
532a478f-d413-41d9-9e97-ad4dc8bf62e6
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
May 04, 2017
Package DI Number
20858690006604
Quantity per Package
50
Contains DI Package
10858690006607
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 93 |