Duns Number:482661753
Device Description: DYNACORD Suture Blue Braided Composite Suture OS-6 36mm 1/2c Reverse Cutting N=1 Number 2 DYNACORD Suture Blue Braided Composite Suture OS-6 36mm 1/2c Reverse Cutting N=1 Number 2 (5 metric), 36 inches (91 cm)
Catalog Number
222065
Brand Name
DYNACORD
Version/Model Number
222065
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
K181182,K181182
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
ae7b3d57-67c9-4bbf-a123-a62de3c433a6
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
November 19, 2018
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 | 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 |