Duns Number:109903521
Device Description: DSCTR D/A CVD CRL
Catalog Number
7205616
Brand Name
NA
Version/Model Number
7205616
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 11, 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"
-
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
K970949
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
9f940918-7500-47f6-ad58-1bf06f245cf4
Public Version Date
December 12, 2019
Public Version Number
5
DI Record Publish Date
August 23, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |