Duns Number:058614483
Device Description: Powered Multifire Endo GIA
Catalog Number
-
Brand Name
Powered Multifire Endo GIA
Version/Model Number
030316L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 02, 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
fdc95990-f7c2-4bef-8996-293b81d5d1cc
Public Version Date
September 09, 2022
Public Version Number
7
DI Record Publish Date
August 28, 2015
Package DI Number
20884523003854
Quantity per Package
6
Contains DI Package
10884523003857
Package Discontinue Date
October 02, 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 |