Duns Number:002144145
Device Description: Green Braided Polyester, Nonabsorbable Surgical Suture
Catalog Number
D8572
Brand Name
ETHIBOND EXCEL
Version/Model Number
D8572
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
-
Product Code
GEA
Product Code Name
CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
1bfadc75-a454-42f1-ac64-aabf3d7d03a7
Public Version Date
October 03, 2022
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
30705031030576
Quantity per Package
12
Contains DI Package
10705031030572
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |