Home GUDID 00190776299880 Millennium
Primary DI 00190776299880
Brand Millennium
Company Avalign Technologies, Inc.
Model 72-23171680
Device description 2-piece Shunt Peritoneal Catheter Passer
Published 2023-11-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 00190776299880 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 00190776299880 00190776299880 190776299880 0190776299880
GMDN Terms# Term, Definition table Term Definition Subcutaneous tunneller, reusable A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt, retinal chip). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a reusable device intended to be sterilized prior to use.
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
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