Duns Number:079402290
Device Description: Green Braided Polyester, Nonabsorbable Surgical Suture
Catalog Number
X4B37G
Brand Name
ETHIBOND EXCEL
Version/Model Number
X4B37G
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
K003070,K003070
Product Code
DXZ
Product Code Name
PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Public Device Record Key
ed8ab8ad-8591-4824-a5da-050613c88fb8
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
January 25, 2018
Package DI Number
30705031239771
Quantity per Package
12
Contains DI Package
10705031239777
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |