Duns Number:192559557
Device Description: Optimus 600 Gravity Drainage Bag w/20" I.T.
Catalog Number
TC600
Brand Name
Gravity Drainage Bag
Version/Model Number
TC600
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 31, 2026
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EXF
Product Code Name
Bag, Bile Collecting
Public Device Record Key
7267cbee-77c4-4c87-a492-9065fd6df542
Public Version Date
April 15, 2022
Public Version Number
5
DI Record Publish Date
September 11, 2017
Package DI Number
H862TC6002
Quantity per Package
2
Contains DI Package
H862TC6001
Package Discontinue Date
October 31, 2026
Package Status
In Commercial Distribution
Package Type
SHIPPER
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 179 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| U | Unclassified | 24 |