Duns Number:002348191
Device Description: 24 EA ISI DA VINCI Si 8MM OBTURATOR
Catalog Number
420023
Brand Name
TAUT
Version/Model Number
IPN006696
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"
-
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
K010007,K010007,K010007
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
5ca8184f-843b-4f5a-b0ad-2ab50481bb2d
Public Version Date
April 28, 2022
Public Version Number
9
DI Record Publish Date
September 16, 2016
Package DI Number
44026704428715
Quantity per Package
4
Contains DI Package
24026704428711
Package Discontinue Date
April 26, 2022
Package Status
Not 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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |