Duns Number:040729840
Device Description: MICTEC PULMONALIS CLAMP WITH FOLDING RATCHET 30 DEGREE CURVED DOWN RIGHT 4.5 MILLIMETER DI MICTEC PULMONALIS CLAMP WITH FOLDING RATCHET 30 DEGREE CURVED DOWN RIGHT 4.5 MILLIMETER DIAMETER 300 MILLIMETER WORKING LENGTH
Catalog Number
20919-34-005
Brand Name
MICTEC PULMONALIS CLAMP
Version/Model Number
20919-34-005
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
-
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
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
6b6f6d83-70a5-4216-8f8d-85fd910cd8a8
Public Version Date
February 18, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2019
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 |