Duns Number:002144145
Device Description: White Polyester, Synthetic Non Absorbable Surgical Suture
Catalog Number
1765G
Brand Name
MERSILENE
Version/Model Number
1765G
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
K946173,K946173
Product Code
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
b161c642-72de-418e-9a30-6e37fd36ee51
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
April 14, 2020
Package DI Number
30705031088355
Quantity per Package
12
Contains DI Package
10705031088351
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 |