Duns Number:058614483
Device Description: Powered Stapler Loading Unit
Catalog Number
-
Brand Name
Powered Multifire Endo GIA
Version/Model Number
030314L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 17, 2019
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
-
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
c54b18f7-f074-40fa-a13d-7a60cbc906c3
Public Version Date
December 07, 2021
Public Version Number
7
DI Record Publish Date
August 28, 2015
Package DI Number
20884523003847
Quantity per Package
6
Contains DI Package
10884523003840
Package Discontinue Date
July 17, 2019
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 |