Duns Number:058614483
Device Description: Circular Stapler with DST Series Technology
Catalog Number
EEAXL21
Brand Name
EEA
Version/Model Number
EEAXL21
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
K062850,K062850
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
593163ff-26a6-4cdf-8ffe-8b0773df1b49
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2015
Package DI Number
20884523005575
Quantity per Package
3
Contains DI Package
10884523005578
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 |