Duns Number:058614483
Device Description: C-Section Stapler with Polysorb Staples
Catalog Number
015140
Brand Name
Premium Poly CS
Version/Model Number
015140
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
K830199,K830199
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
b7a37ba4-6e00-45dc-923e-0fd45314e518
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 12, 2015
Package DI Number
20884521047652
Quantity per Package
3
Contains DI Package
10884521047655
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |