Duns Number:961027315
Device Description: Tiburon Major Abdominal Drape with Pouches
Catalog Number
9457
Brand Name
CONVERTORS
Version/Model Number
9457
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 08, 2021
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
3323efa9-822b-42fc-82e9-2fb994f71b00
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
September 28, 2017
Package DI Number
50885380141308
Quantity per Package
12
Contains DI Package
10885380141300
Package Discontinue Date
March 08, 2021
Package Status
Not 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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |