Home GUDID 00630094480503 Bioseal Inc.
Primary DI 00630094480503
Brand Bioseal Inc.
Company BIOSEAL
Model DURA050/100
Device description Duraholder 12.5" x 9"
Published 2025-05-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true 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 10630094480500 Primary GS1 0 00630094480503 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10630094480500 10630094480500 00630094480503 00630094480503 630094480503 0630094480503
GMDN Terms# Term, Definition table Term Definition Surgical instrument interim-placement holder, single-use A device intended to be used in the operating room (OR) by staff to safely hold a hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors, robotic system instrument hand-held remote controller] when not in use during surgery, to avoid damage to the instrument, maintain its sterility, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device.
Regulatory Flags# DUNS number 186968939 Device count 100 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 false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00198506091988 ELMED INCORPORATED ELMED INCORPORATED MDM 2026-07-22 00198506093470 ELMED INCORPORATED ELMED INCORPORATED MDM 2026-07-22 00840456215753 JMU JMU DENTAL, INC MDM 2026-07-22 00840456218600 JMU JMU DENTAL, INC MDM 2026-07-22 00840456218617 JMU JMU DENTAL, INC MDM 2026-07-22 00190776403744 Millennium Avalign Technologies, Inc. MDM 2026-07-21 00810005668125 Trigon NVision Biomedical Technologies, Inc. MDM 2026-04-24 00810005667227 Trigon NVision Biomedical Technologies, Inc. MDM 2025-12-19 00810135963169 Impact NVision Biomedical Technologies, Inc. MDM 2025-09-22 00810135963183 Impact NVision Biomedical Technologies, Inc. MDM 2025-09-22 00810135963251 Impact NVision Biomedical Technologies, Inc. MDM 2025-09-22 00810135963275 Impact NVision Biomedical Technologies, Inc. MDM 2025-09-22 00810135962865 Trigon NVision Biomedical Technologies, Inc. MDM 2025-07-25 00810135962889 Trigon NVision Biomedical Technologies, Inc. MDM 2025-07-25 00810135962896 Trigon NVision Biomedical Technologies, Inc. MDM 2025-07-25 00810135962902 Trigon NVision Biomedical Technologies, Inc. MDM 2025-07-25 00810135962919 Trigon NVision Biomedical Technologies, Inc. MDM 2025-07-25 00810135962926 Trigon NVision Biomedical Technologies, Inc. MDM 2025-07-25 00810135962933 Trigon NVision Biomedical Technologies, Inc. MDM 2025-07-25 00810135963435 Trigon NVision Biomedical Technologies, Inc. MDM 2025-07-25 00810005668040 Caliber Intramedullary Fixation System NVision Biomedical Technologies, Inc. MDM 2025-07-21 00810135963046 Caliber Intramedullary Fixation System NVision Biomedical Technologies, Inc. MDM 2025-07-21 00810135963053 Caliber Intramedullary Fixation System NVision Biomedical Technologies, Inc. MDM 2025-07-21 00810135963060 Caliber Intramedullary Fixation System NVision Biomedical Technologies, Inc. MDM 2025-07-21 00810135963077 Caliber Intramedullary Fixation System NVision Biomedical Technologies, Inc. MDM 2025-07-21 00810135963084 Caliber Intramedullary Fixation System NVision Biomedical Technologies, Inc. MDM 2025-07-21 00810135963091 Caliber Intramedullary Fixation System NVision Biomedical Technologies, Inc. MDM 2025-07-21 00810135963107 Caliber Intramedullary Fixation System NVision Biomedical Technologies, Inc. MDM 2025-07-21 00810135962650 Trigon NVision Biomedical Technologies, Inc. MDM 2025-05-27 00810135962667 Trigon NVision Biomedical Technologies, Inc. MDM 2025-05-27