Home GUDID B382SD9081971030 Surgical Direct
Primary DI B382SD9081971030
Brand Surgical Direct
Company Surgical Direct, Inc.
Model SD908197103
Catalog number SD908197103
Device description 5" Cooley Dilator, 3mm
Published 2026-07-17
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 false Product Codes# Code, Name table Code Name DWP Dilator, Vessel, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWP Dilator, Vessel, Surgical Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B382SD9081971030 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Vascular dilator, reusable A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 124367223 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 false 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 00190776400347 Millennium Avalign Technologies, Inc. DWP 2026-07-17 B382SD9081971000 Surgical Direct Surgical Direct, Inc. DWP 2026-07-17 B382SD9081971010 Surgical Direct Surgical Direct, Inc. DWP 2026-07-17 B382SD9081971020 Surgical Direct Surgical Direct, Inc. DWP 2026-07-17 B382SD9081971040 Surgical Direct Surgical Direct, Inc. DWP 2026-07-17 B382S8711000 Surgical Direct Surgical Direct, Inc. DWP 2026-07-14 B382S8711010 Surgical Direct Surgical Direct, Inc. DWP 2026-07-14 B382S8711020 Surgical Direct Surgical Direct, Inc. DWP 2026-07-14 00192896123359 Sarns Myocardial Dilator SONTEC INSTRUMENTS, INC. DWP 2026-04-23 14026704927873 PILLING TELEFLEX INCORPORATED DWP 2025-09-30 14026704927880 PILLING TELEFLEX INCORPORATED DWP 2025-09-30 14026704927897 PILLING TELEFLEX INCORPORATED DWP 2025-09-30 14026704927903 PILLING TELEFLEX INCORPORATED DWP 2025-09-30 04058749118780 NA Fehling Instruments GmbH & Co. KG DWP 2024-01-08 04058749118797 NA Fehling Instruments GmbH & Co. KG DWP 2024-01-08 34026704652618 PILLING TELEFLEX INCORPORATED DWP 2020-09-16 34026704652625 PILLING TELEFLEX INCORPORATED DWP 2020-09-16 34026704652632 PILLING TELEFLEX INCORPORATED DWP 2020-09-16 34026704652649 PILLING TELEFLEX INCORPORATED DWP 2020-09-16 34026704652656 PILLING TELEFLEX INCORPORATED DWP 2020-09-16 34026704652670 PILLING TELEFLEX INCORPORATED DWP 2020-09-16 34026704652687 PILLING TELEFLEX INCORPORATED DWP 2020-09-16 34026704655961 PILLING TELEFLEX INCORPORATED DWP 2020-09-16 34026704652663 PILLING TELEFLEX INCORPORATED DWP 2020-03-23 00192896010703 GARRETT VASCULAR DILATOR SONTEC INSTRUMENTS, INC. DWP 2018-08-29 00192896005563 GARRETT VASCULAR DILATOR SONTEC INSTRUMENTS, INC. DWP 2018-08-24 00192896010680 GARRETT VASCULAR DILATOR SONTEC INSTRUMENTS, INC. DWP 2018-08-24 00192896010697 GARRETT VASCULAR DILATOR SONTEC INSTRUMENTS, INC. DWP 2018-08-24 00192896010710 TUNNELER SONTEC INSTRUMENTS, INC. DWP 2018-08-24 00192896010727 TUBBS MITRAL VALVE DILATOR SONTEC INSTRUMENTS, INC. DWP 2018-08-24
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