Duns Number:002348191
Device Description: 24 EA ISI DA VINCI Si 8MM OBTURATOR
Catalog Number
420023
Brand Name
TAUT
Version/Model Number
IPN028436
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K010007,K010007,K010007,K010007
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
a2c1e7ff-a593-4910-a14b-6b262c716f8b
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
January 06, 2021
Package DI Number
24026704629583
Quantity per Package
6
Contains DI Package
14026704629586
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 | 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 |