Duns Number:080935429
Device Description: Pneumothorax Procedure Tray with Safety Components,8 Fr/Ch x 3-1/2 inch (2.7 mm x 8.9 cm) Pneumothorax Procedure Tray with Safety Components,8 Fr/Ch x 3-1/2 inch (2.7 mm x 8.9 cm) Catheter
Catalog Number
8888567032
Brand Name
Turkel
Version/Model Number
8888567032
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K934428,K934428
Product Code
LRO
Product Code Name
General surgery tray
Public Device Record Key
673b9ec4-8ea6-413c-b0ae-0d80cfabf658
Public Version Date
February 15, 2019
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20884521020624
Quantity per Package
5
Contains DI Package
10884521020627
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |