Duns Number:058614483
Device Description: Loading Unit with Polysorb Staples
Catalog Number
-
Brand Name
Premium Polysorb
Version/Model Number
013507L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 09, 2020
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
b0599285-b172-4cee-b65f-94a8bd66e9fe
Public Version Date
September 14, 2022
Public Version Number
6
DI Record Publish Date
August 28, 2015
Package DI Number
20884521047607
Quantity per Package
6
Contains DI Package
10884521047600
Package Discontinue Date
December 09, 2020
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 | 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 |