Duns Number:040729840
Device Description: MICTEC SPRAY NOZZLE WITH BELLOWS FOR TALC POWDER WITH ROTABLE CONNECTION TUBE DOUBLE ANGLE MICTEC SPRAY NOZZLE WITH BELLOWS FOR TALC POWDER WITH ROTABLE CONNECTION TUBE DOUBLE ANGLED
Catalog Number
20943-60
Brand Name
MICTEC SPRAY NOZZLE
Version/Model Number
20943-60
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
K002877
Product Code
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
aabeaf15-8200-4461-8f56-2ae6a7205c8c
Public Version Date
September 17, 2018
Public Version Number
1
DI Record Publish Date
August 15, 2018
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 |