Duns Number:829465157
Device Description: Green Braided Nonabsorble Suture, Coated with Polybutilate
Catalog Number
10X07
Brand Name
ETHIBOND
Version/Model Number
10X07
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 18, 2018
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
K946173,K946173
Product Code
GAQ
Product Code Name
SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
Public Device Record Key
d6598197-93ef-45df-91a3-0e24840c6426
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
September 01, 2015
Package DI Number
30705031001262
Quantity per Package
12
Contains DI Package
10705031001268
Package Discontinue Date
January 18, 2018
Package Status
Not 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 |