Duns Number:058614483
Device Description: Loading Unit with DST Series Technology
Catalog Number
GIA8038L
Brand Name
GIA
Version/Model Number
GIA8038L
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
50983876-d9e5-4d2c-b450-34f9dbd0ee79
Public Version Date
May 07, 2019
Public Version Number
5
DI Record Publish Date
September 01, 2015
Package DI Number
20884523007258
Quantity per Package
6
Contains DI Package
10884523007251
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 |