Duns Number:600319250
Device Description: Sample of the FasTouch™ Absorbable Fixation System - 25 Absorbable Fasteners
Catalog Number
SFTA25
Brand Name
FasTouch™ Absorbable
Version/Model Number
SFTA25
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K181668,K181668
Product Code
GDW
Product Code Name
Staple, Implantable
Public Device Record Key
f3f70f29-7d63-4427-81b5-1591a054618f
Public Version Date
September 23, 2019
Public Version Number
1
DI Record Publish Date
September 14, 2019
Package DI Number
17290017155248
Quantity per Package
5
Contains DI Package
07290017155241
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |