Duns Number:342243334
Device Description: Carbon-handle w.ratchet,w.HF-conn.
Catalog Number
19.260
Brand Name
Carbon-handle w.ratchet,w.HF-conn.
Version/Model Number
19.260
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
25013823-c1f1-4d0e-83f7-4db881e1a278
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 03, 2016
Package DI Number
EMAH192601
Quantity per Package
1
Contains DI Package
EMAH192600
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 1976 |