Duns Number:482661753
Device Description: 2-0 ORTHOCORD (3 Free Strands) with Meniscal Needle ORTHOCORD Violet braided composite sut 2-0 ORTHOCORD (3 Free Strands) with Meniscal Needle ORTHOCORD Violet braided composite suture (3 free strands), size 2-0 (3 metric), 38 Inches (96.5cm) with single 10 Inches (25.4cm) meniscal needle (1) with wire loop.
Catalog Number
228145
Brand Name
ORTHOCORD
Version/Model Number
228145
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
K080918,K080918
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
9545c0e3-ccd8-42a4-afae-d0936625c1fc
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
20886705010070
Quantity per Package
5
Contains DI Package
10886705010073
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACKAGE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |