IC Accessory Kit

GUDID 00861810000310

IMPLICIT CARE LLC

Polyester suture, non-bioabsorbable, multifilament
Primary Device ID00861810000310
NIH Device Record Keyd77b3375-d8f2-4493-83bd-d72f2ae294a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameIC Accessory Kit
Version Model NumberIML-02
Company DUNS006341466
Company NameIMPLICIT CARE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com
Phone949-6809653
Emailsummer@icledsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100861810000310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-22
Device Publish Date2016-09-14

Devices Manufactured by IMPLICIT CARE LLC

00861810000303 - ICLED™ Surgical Suture System2019-07-22 The device designed to efficiently and accurately place the suture for the purpose of performing approximation of tissue and el
00861810000310 - IC Accessory Kit2019-07-22
00861810000310 - IC Accessory Kit2019-07-22

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.