Duns Number:058614483
Device Description: Circular Stapler with DST Series Technology
Catalog Number
-
Brand Name
EEA
Version/Model Number
EEA2535
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062850,K062850
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
29f739c5-9fce-4823-8b88-1f07b749764d
Public Version Date
June 02, 2022
Public Version Number
5
DI Record Publish Date
September 01, 2015
Package DI Number
20884523004745
Quantity per Package
3
Contains DI Package
10884523004748
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack_or_Inner_Pack
| 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 |