Home GUDID 00190776413095
Millennium
Primary DI 00190776413095
Brand Millennium
Company Avalign Technologies, Inc.
Model 1-BT478RM
Device description "Richardson Retractor Loop Handle 3/4"" x 2.5"""
Published 2025-10-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Product Codes# Code, Name table Code Name GEN Forceps, General & Plastic Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEN Forceps, General & Plastic Surgery General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776413095 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 00190776413095 00190776413095 190776413095 0190776413095
GMDN Terms# Term, Definition table Term Definition Hand-held surgical retractor, reusable A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 792528510 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198506091476 ELMED INCORPORATED ELMED INCORPORATED GEN 2026-06-09 00810189451506 Surgical Design Surgical Design, Inc. GEN 2026-06-06 00198506091230 ELMED INCORPORATED ELMED INCORPORATED GEN 2026-06-03 G383S1061WM1413S3 SURJEX SURJEX GEN 2026-05-31 G383S1061WM3240913 SURJEX SURJEX GEN 2026-05-31 G383WM3241113 SURJEX SURJEX GEN 2026-05-31 00810055250929 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810055250936 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810055250943 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450264 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450271 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450288 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450295 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450301 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450318 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450325 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450332 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450349 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450356 Surgical Design Surgical Design, Inc. GEN 2026-05-29 00810189450363 Surgical Design Surgical Design, Inc. GEN 2026-05-29 G043201100 BEAR Bear-Ent, LLC GEN 2026-04-17 G043201130 BEAR Bear-Ent, LLC GEN 2026-04-17 G043201140 BEAR Bear-Ent, LLC GEN 2026-04-17 G043201160 BEAR Bear-Ent, LLC GEN 2026-04-17 G043201190 BEAR Bear-Ent, LLC GEN 2026-04-17 G043201200 BEAR Bear-Ent, LLC GEN 2026-04-17 09348811008756 INKA The Trustee for KAISER FAMILY TRUST GEN 2025-11-19 09348811009029 INKA The Trustee for KAISER FAMILY TRUST GEN 2025-11-19 09348811009050 INKA The Trustee for KAISER FAMILY TRUST GEN 2025-11-19 09348811009135 INKA The Trustee for KAISER FAMILY TRUST GEN 2025-11-19