Catalog Number
-
Brand Name
ILA
Version/Model Number
3971
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 20, 2020
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
K885222,K885222
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
20269187-ac1c-4ba2-8d0e-e3f91efcf047
Public Version Date
April 12, 2022
Public Version Number
6
DI Record Publish Date
August 28, 2015
Package DI Number
20884521063164
Quantity per Package
6
Contains DI Package
10884521063167
Package Discontinue Date
February 20, 2020
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 |