Duns Number:006341466
Device Description: The device designed to efficiently and accurately place the suture for the purpose of per The device designed to efficiently and accurately place the suture for the purpose of performing approximation of tissue and elevation of subdermis/underlying muscle procedure. All components are sterile and intended for single use only.
Catalog Number
-
Brand Name
ICLED™ Surgical Suture System
Version/Model Number
70001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAT
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Public Device Record Key
e0e31690-68e6-4d34-b0cd-d06eb25bc303
Public Version Date
April 25, 2022
Public Version Number
6
DI Record Publish Date
August 17, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |