Duns Number:600505107
Device Description: OSSIOfiber® Suture Anchor System - Two 4.75 mm with Tape, #2 Sutures, with Needles. Packa OSSIOfiber® Suture Anchor System - Two 4.75 mm with Tape, #2 Sutures, with Needles. Package contains: 1 OSSIOfiber Suture Anchor, 4.75 mm, Black Tape & Blue/White #2 Sutures with Needles; 1 OSSIOfiber Suture Anchor, 4.75 mm, Black/White Tape & Blue #2 Sutures with Needles; 1 OSSIO Drill Bit & Drill Guide.
Catalog Number
OF2034756S
Brand Name
OSSIOfiber® Suture Anchor System
Version/Model Number
OF2034756S
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
-
Product Code
OJH
Product Code Name
Orthopedic Tray
Public Device Record Key
c2e5ce17-ab33-49b8-bfb5-1c302332c8b4
Public Version Date
June 14, 2022
Public Version Number
1
DI Record Publish Date
June 06, 2022
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |