Duns Number:071595540
Device Description: TROGARD MINI-FINESSE DILATING CONICAL BLUNT TIP LAPAROSCOPIC ACCESS SYSTEM, 5MM
Catalog Number
60-6050-016
Brand Name
TROGARD FINESSE
Version/Model Number
60-6050-016
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 07, 2022
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
K001597,K001597,K001597
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
827b2778-3d10-42e2-ad2d-9060fa7b1ac0
Public Version Date
June 08, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20653405036422
Quantity per Package
6
Contains DI Package
10653405036425
Package Discontinue Date
June 07, 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |