Home GUDID G559FB1030000 HyperFlex® Reduction Clamp
Primary DI G559FB1030000
Brand HyperFlex® Reduction Clamp
Company HYPERFLEX MEDICAL INC.
Model FB-1030-00
Device description FootBridge Reduction Clamp
Published 2025-06-12
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 LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G559FB1030000 Primary HIBCC 0
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 119512231 Device count 1 Premarket exempt true Lot or batch true Serial number true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published G559HF2111LFT0 HyperFlex® Bunion Correction System HF-2111-LFT 2026-01-01 G559HF2111RT0 HyperFlex® Bunion Correction System HF-2111-RT 2026-01-01 G559HF2121LFT0 HyperFlex® Bunion Correction System HF-2121-LFT 2026-01-01 G559HF2121RT0 HyperFlex® Bunion Correction System HF-2121-RT 2026-01-01 G559HF2131LFT0 HyperFlex® Bunion Correction System HF-2131-LFT 2026-01-01 G559HF2131RT0 HyperFlex® Bunion Correction System HF-2131-RT 2026-01-01 G559HF2211LFT0 HyperFlex® Bunion Correction System HF-2211-LFT 2026-01-01 G559HF2211RT0 HyperFlex® Bunion Correction System HF-2211-RT 2026-01-01 G559HF2221LFT0 HyperFlex® Bunion Correction System HF-2221-LFT 2026-01-01 G559HF2221RT0 HyperFlex® Bunion Correction System HF-2221-RT 2026-01-01 G559HF2231LFT0 HyperFlex® Bunion Correction System HF-2231-LFT 2026-01-01 G559HF2231RT0 HyperFlex® Bunion Correction System HF-2231-RT 2026-01-01 G559HF2311LFT0 HyperFlex® Bunion Correction System HF-2311-LFT 2026-01-01 G559HF2311RT0 HyperFlex® Bunion Correction System HF-2311-RT 2026-01-01 G559HF2321LFT0 HyperFlex® Bunion Correction System HF-2321-LFT 2026-01-01 G559HF2321RT0 HyperFlex® Bunion Correction System HF-2321-RT 2026-01-01 G559HF2331LFT0 HyperFlex® Bunion Correction System HF-2331-LFT 2026-01-01 G559HF2331RT0 HyperFlex® Bunion Correction System HF-2331-RT 2026-01-01 G559HF29000 HyperFlex® Bunion Correction System HF-2900 2026-01-01 G559HF2910LFT0 HyperFlex® Bunion Correction System HF-2910-LFT 2026-01-01
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