Duns Number:832637081
Device Description: OPENING CANNULA Ø16/Ø13.5MM X 100MM
Catalog Number
SD357020
Brand Name
NA
Version/Model Number
SD357.020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 01, 2018
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
GEA
Product Code Name
CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
d8ea0f36-92bd-414a-b133-51f56e3ef410
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
December 31, 2016
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 | 1194 |
2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
3 | A medical device with high risk that requires premarket approval | 30 |
U | Unclassified | 1 |