Home GUDID 00842071144623
TLC Self-Retaining Retractor System
Primary DI 00842071144623
Brand TLC Self-Retaining Retractor System
Company APPLIED MEDICAL TECHNOLOGY, INC.
Model ETLC400
Catalog number ETLC400, TLC400
Device description TLC400 TLC Self-Retaining Retractor Frame (Sterile, Pouched), MDR
Published 2024-10-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name GAD Retractor
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAD Retractor General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842071144623 Package GS1 1 In Commercial Distribution 00842071144371 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00842071144623 00842071144623 842071144623 0842071144623 00842071144371 00842071144371 842071144371 0842071144371
GMDN Terms# Term, Definition table Term Definition Surgical retraction system mounting frame, single-use A noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a single-use device.
Regulatory Flags# DUNS number 038101861 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00842071153144 AMT MiniONE Extension Set E8-2455-ISOSAF E8-2455-ISOSAF, 8-2455-ISOSAF 2026-05-13 00842071147198 MINI Balloon Button 5-2427 2026-05-07 00842071147204 MINI Balloon Button 5-2427-I 5-2427-I 2026-05-07 00842071153045 AMT MiniSPC Drainage Set ES1-1221 ES1-1221, S1-1221 2026-04-28 00842071153069 AMT MiniSPC Drainage Set ES1-2421 ES1-2421, S1-2421 2026-04-28 00842071146276 MINI Balloon Button 5-1455 5-1455 2026-04-09 00842071146283 MINI Balloon Button 5-1455-I 5-1455-I 2026-04-09 00842071148935 GEMINI Suture Loop ES4-8000 ES4-8000, S4-8000 2025-04-07 00842071151119 RHAPSO ESD110-S-07 ESD110-S-07, SD110-S-07-101, SD110-S-07-105 2026-03-25 00842071151140 RHAPSO ESD110-C-07 ESD110-C-07, SD110-C-07-101, SD110-C-07-105 2026-03-25 00842071153021 AMT MiniONE Extension Set E8-1255-ISOSAF E8-1255-ISOSAF, 8-1255-ISOSAF 2026-03-23 00842071153038 AMT MiniONE Extension Set E8-1255-ISOSAF E8-1255-ISOSAF, 8-1255-ISOSAF 2026-03-23 00842071150952 AMT MiniSPC Drainage Set ES1-1221 ES1-1221, S1-1221 2026-03-18 00842071150976 AMT MiniSPC Drainage Set ES1-2421 ES1-2421, S1-2421 2026-03-18 00842071152758 MiniSPC Button SPC-2425-12 SPC-2425-12 2026-03-18 00842071152765 MiniSPC Button SPC-2425-24 SPC-2425-24 2026-03-18 00842071152772 MiniSPC Button SPC-2427-12 SPC-2427-12 2026-03-18 00842071152789 MiniSPC Button SPC-2427-24 SPC-2427-24 2026-03-18 00842071152796 MiniSPC Button SPC-2430-12 SPC-2430-12 2026-03-18 00842071152802 MiniSPC Button SPC-2430-24 SPC-2430-24 2026-03-18
Other Devices Sharing Product Codes#