ICLED™ Surgical Suture System
GUDID 00861810000303
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.
IMPLICIT CARE LLC
Polyester suture, non-bioabsorbable, multifilament| Primary Device ID | 00861810000303 |
| NIH Device Record Key | e0e31690-68e6-4d34-b0cd-d06eb25bc303 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ICLED™ Surgical Suture System |
| Version Model Number | 70001 |
| Company DUNS | 006341466 |
| Company Name | IMPLICIT CARE LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861810000303 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091061
FDA Product Code
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-07-22 |
| Device Publish Date | 2016-08-17 |
Devices Manufactured by IMPLICIT CARE LLC
| 00861810000303 - ICLED™ Surgical Suture System | 2019-07-22The 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. |
| 00861810000303 - ICLED™ Surgical Suture System | 2019-07-22 The device designed to efficiently and accurately place the suture for the purpose of performing approximation of tissue and el |
| 00861810000310 - IC Accessory Kit | 2019-07-22 |
Trademark Results [ICLED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICLED 86601222 4862891 Live/Registered |
ImplicitCare, LLC 2015-04-17 |
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