Home GUDID 00843059101423 TSI
Primary DI 00843059101423
Brand TSI
Company TEDAN SURGICAL INNOVATIONS, L.L.C.
Model BW-0128
Device description MALLEABLE BLADE, 2 X 6"
Published 2017-08-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name MDM Instrument, Manual, Surgical, General Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00843059101423 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 00843059101423 00843059101423 843059101423 0843059101423
GMDN Terms# Term, Definition table Term Definition Surgical retractor/retraction system blade, reusable A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 791619393 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 false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00810220800171 Adler Instrument Company Adler, Inc. MDM 2026-05-26 00810220800188 Adler Instrument Company Adler, Inc. MDM 2026-05-26 06438394002678 Activa Instrument Bioretec Oy MDM 2026-03-23 06438394002685 Activa Instrument Bioretec Oy MDM 2026-03-23 06438394002692 Activa Instrument Bioretec Oy MDM 2026-03-23 06438394020382 Activa Instrument Bioretec Oy MDM 2026-03-23 06438394010956 Activa Instrument Bioretec Oy MDM 2026-03-23 00198506089619 ELMED INCORPORATED ELMED INCORPORATED MDM 2026-03-17 00888867519459 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867519473 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867519503 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867519510 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867529755 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867529793 Arthrex® ARTHREX, INC. MDM 2026-03-16 00888867529823 Arthrex® ARTHREX, INC. MDM 2026-03-16 00198506089510 ELMED INCORPORATED ELMED INCORPORATED MDM 2026-03-13 00810158219236 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219243 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219250 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219281 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219304 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219311 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219359 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219373 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-12 00810158219007 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11 00810158219014 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11 00810158219021 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11 00810158219038 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11 00810158219069 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11 00810158219090 PRINCETON Princeton Medical Group, Inc. MDM 2026-03-11