Duns Number:016889401
Catalog Number
-
Brand Name
Covidien
Version/Model Number
UNVCA5SHF
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"
-
For Single-Use
Yes
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
K172093,K172093
Product Code
NLM
Product Code Name
Laparoscope, General & Plastic Surgery, Reprocessed
Public Device Record Key
676fad7a-0bc0-4d31-b7c2-519351331ab6
Public Version Date
March 01, 2021
Public Version Number
6
DI Record Publish Date
December 01, 2017
Package DI Number
B504UNVCA5SHF1
Quantity per Package
6
Contains DI Package
B504UNVCA5SHF0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3993 |
2 | A medical device with a moderate to high risk that requires special controls. | 1216 |