Duns Number:058614483
Device Description: Universal Articulating Loading Unit
Catalog Number
-
Brand Name
Endo GIA
Version/Model Number
030451
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K111825,K111825
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
90d235b6-4f77-4f01-b46f-7c666ff9209a
Public Version Date
December 07, 2021
Public Version Number
9
DI Record Publish Date
August 28, 2015
Package DI Number
20884523002826
Quantity per Package
6
Contains DI Package
10884523002829
Package Discontinue Date
-
Package Status
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 |