Duns Number:095979332
Device Description: PERCLOSE A-T 6F Suture-Medicated Closure System
Catalog Number
12337-04
Brand Name
PERCLOSE
Version/Model Number
12337-04
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 24, 2019
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"
Yes
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
MGB
Product Code Name
DEVICE, HEMOSTASIS, VASCULAR
Public Device Record Key
55d69b03-49af-4f34-86aa-260a11ba7c28
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
November 14, 2014
Package DI Number
28717648013069
Quantity per Package
10
Contains DI Package
08717648013065
Package Discontinue Date
February 24, 2019
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 964 |
| 3 | A medical device with high risk that requires premarket approval | 775 |