Duns Number:482661753
Device Description: ORTHOCORD Violet Braided Composite Suture Meets U.S.P. and E.P. except for diameter 2 (5 m ORTHOCORD Violet Braided Composite Suture Meets U.S.P. and E.P. except for diameter 2 (5 metric), 36 Inches (91 cm)
Catalog Number
223105
Brand Name
ORTHOCORD
Version/Model Number
223105
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
K040004,K040004
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
a34b2335-8da5-4a5c-8c97-bd964eb0dd57
Public Version Date
July 23, 2021
Public Version Number
7
DI Record Publish Date
September 01, 2015
Package DI Number
20886705008763
Quantity per Package
12
Contains DI Package
10886705008766
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 |