Duns Number:079402290
Device Description: ETHICON SECURESTRAP ABSORBABLE FIXATION DEVICE
Catalog Number
STRAP12, STRAP12R
Brand Name
ETHICON SECURESTRAP
Version/Model Number
STRAP12
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
K093845,K093845
Product Code
GDW
Product Code Name
STAPLE, IMPLANTABLE
Public Device Record Key
5aaec2f6-0cca-493a-a6b2-1c258159c8c4
Public Version Date
January 18, 2022
Public Version Number
7
DI Record Publish Date
September 23, 2015
Package DI Number
30705031132980
Quantity per Package
6
Contains DI Package
10705031132986
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |