Duns Number:040729840
Device Description: MICTEC INJECTION CANNULA CURVED SMALL LUER LOCK G22
Catalog Number
-
Brand Name
MICTEC INJECTION CANNULA
Version/Model Number
20941-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 23, 2018
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
-
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
K002877
Product Code
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
7175d022-94f0-4cf2-9ce9-2862dc0bbda9
Public Version Date
September 24, 2018
Public Version Number
7
DI Record Publish Date
September 30, 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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |