Home GUDID H981SD038160270 NA
Primary DI H981SD038160270
Brand NA
Company SYNTHES (U.S.A.) LP
Model SD03.816.027
Catalog number SD03816027
Device description 9MM SOFT TISSUE RETRACTOR SCOOP
Published 2016-12-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GAD RETRACTOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAD Retractor General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10705034705132 Primary GS1 0 H981SD038160270 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10705034705132 10705034705132
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 832637081 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 00198506091926 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-22 00198506092015 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-22 00198506093685 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-22 00841731153104 ARTEMIS FUZE VILEX LLC GAD 2026-07-22 00841731153111 ARTEMIS FUZE VILEX LLC GAD 2026-07-22 B8038600980 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8038600990 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803860120L0 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8038601250 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039018420 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039018430 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039018840 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039030020 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803903220010 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803903220020 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039401000 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601360 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601370 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601390 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601400 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803NL97010 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803NL9701H0 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 00190776402174 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00190776403317 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00190776403324 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00190776403362 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00840183532185 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21 00840183532192 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21 00840183532222 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21 00840183532239 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21
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