Duns Number:058614483
Device Description: Stapler with DST Series Technology
Catalog Number
GIA10038S
Brand Name
GIA
Version/Model Number
GIA10038S
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
K111825,K111825
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
33dc4c77-8637-4d31-84e0-0cb2772d0b4f
Public Version Date
July 16, 2019
Public Version Number
4
DI Record Publish Date
September 01, 2015
Package DI Number
20884521031675
Quantity per Package
3
Contains DI Package
30884521031672
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 |