Duns Number:190572854
Device Description: RC Loop (DS) Anchor w / ORTHOCORD With two Number 2 (5 metric) ORTHOCORD Braided Composite RC Loop (DS) Anchor w / ORTHOCORD With two Number 2 (5 metric) ORTHOCORD Braided Composite Sutures, 36 Inches (91cm), Violet and Blue, each armed with 2 MO-7 Tapered needles. Size 2 (5 metric) ORTHOCORD eyelet loop.
Catalog Number
222982
Brand Name
ORTHOCORD
Version/Model Number
222982
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
-
Product Code
JDR
Product Code Name
STAPLE, FIXATION, BONE
Public Device Record Key
356c732e-357a-4384-9d00-e75921cfc384
Public Version Date
March 21, 2019
Public Version Number
4
DI Record Publish Date
September 01, 2015
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 | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |