Catalog Number
-
Brand Name
EEA
Version/Model Number
110214L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2022
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
K771178,K771178
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
d220cdef-0e8b-4f94-b452-1a5d1bdaa4d1
Public Version Date
April 26, 2022
Public Version Number
9
DI Record Publish Date
August 28, 2015
Package DI Number
20884523006541
Quantity per Package
6
Contains DI Package
10884523006544
Package Discontinue Date
April 22, 2022
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 |