Duns Number:600087854
Device Description: Single Use Cannula with Integrated Port Closure Systemfor use *only* with a TroClose1200™ Single Use Cannula with Integrated Port Closure Systemfor use *only* with a TroClose1200™ Obturator (found in REF# GSTC1200)
Catalog Number
-
Brand Name
TroClose1200™
Version/Model Number
GSTC1200C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K171494,K171494,K171494
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
6210de8a-97da-44a6-a3ca-dde36f7c2192
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 07, 2017
Package DI Number
27290017191014
Quantity per Package
2
Contains DI Package
17290017191017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |