Duns Number:658122465
Device Description: OPTICAL TROCAR 5-12+MM/100MM
Catalog Number
-
Brand Name
BluView
Version/Model Number
BV-12X100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2019
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
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
-
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
d6d58f0d-b67d-4f5f-badb-9d3218b13041
Public Version Date
February 17, 2020
Public Version Number
5
DI Record Publish Date
April 10, 2019
Package DI Number
20412786063256
Quantity per Package
12
Contains DI Package
10412786063259
Package Discontinue Date
October 31, 2019
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 67 |