Duns Number:001191048
Device Description: CapSure Permanent Fixation System 15 Permanent Fasteners
Catalog Number
0113215
Brand Name
CapSure Permanent Fixation System
Version/Model Number
0113215
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
60998134-07a1-40e3-a80c-8aff18b53d9d
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
June 22, 2015
Package DI Number
10801741094986
Quantity per Package
5
Contains DI Package
00801741094989
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |