Duns Number:961027315
Device Description: Tiburon Transverse Laparotomy Sheet
Catalog Number
29421
Brand Name
CONVERTORS
Version/Model Number
29421
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 10, 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
KKX
Product Code Name
Drape, surgical
Public Device Record Key
4719b00b-78a4-41ca-ae3d-347e0b6e58f0
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
June 28, 2016
Package DI Number
50630140025455
Quantity per Package
12
Contains DI Package
10630140025457
Package Discontinue Date
July 10, 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 |