Duns Number:079700711
Device Description: Hercules™ FT Suture Anchor, 2.0 mm x 6.5 mm with two 3-0 BightForce Suture and tapered 1/ Hercules™ FT Suture Anchor, 2.0 mm x 6.5 mm with two 3-0 BightForce Suture and tapered 1/2 circle needles
Catalog Number
-
Brand Name
Hercules Suture Anchor System
Version/Model Number
A20 SP220
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"
-
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
K201636
Product Code
MBI
Product Code Name
Fastener, Fixation, Nondegradable, Soft Tissue
Public Device Record Key
fbf42890-36ca-42ce-a5c8-ae29a3baf45b
Public Version Date
December 22, 2020
Public Version Number
1
DI Record Publish Date
December 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 113 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1255 |