Duns Number:071595540
Device Description: 16 X 15MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3
Catalog Number
7615-03
Brand Name
STAPLIZER
Version/Model Number
7615-03
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
K840566,K840566,K840566
Product Code
JDR
Product Code Name
STAPLE, FIXATION, BONE
Public Device Record Key
23ba8a49-4ee8-4b9d-a681-8af08444dd77
Public Version Date
November 23, 2021
Public Version Number
4
DI Record Publish Date
October 24, 2015
Package DI Number
20845854016425
Quantity per Package
3
Contains DI Package
10845854016428
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |