Duns Number:080914995
Catalog Number
-
Brand Name
Thoracic Drain
Version/Model Number
TC-xxxxx
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
-
Product Code
GBS
Product Code Name
CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY
Public Device Record Key
709f1be0-4605-4366-b2a1-abbfc17d9b81
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
July 16, 2015
Package DI Number
10803622105934
Quantity per Package
10
Contains DI Package
00803622105937
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 | 44 |
2 | A medical device with a moderate to high risk that requires special controls. | 479 |
3 | A medical device with high risk that requires premarket approval | 30 |