Home GUDID H981SD3888320 NA
Primary DI H981SD3888320
Brand NA
Company Synthes GmbH
Model SD388.832
Catalog number SD388832
Device description BI-PLANAR PERSUADER
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 HTC PLIERS, SURGICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTC Pliers, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10705034707266 Primary GS1 0 H981SD3888320 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10705034707266 10705034707266
GMDN Terms# Term, Definition table Term Definition Orthopaedic rod reducer A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 486711679 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 B8034605720 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034605730 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034605740 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034709290 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034802540 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034802570 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 B8034802580 ORTHOMED ORTHO-MED, INC. HTC 2026-07-14 10887587077628 NA Synthes GmbH HTC 2024-08-21 B356KJ666140 American Medicals American Medicals HTC 2024-07-11 10840199539458 Forcep KOROS U.S.A., INC. HTC 2024-02-01 10840199539489 Forcep KOROS U.S.A., INC. HTC 2024-02-01 10840199535900 Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199535962 C Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199535993 Aortic Clamp KOROS U.S.A., INC. HTC 2024-01-31 10840199536006 Aortic Clamp KOROS U.S.A., INC. HTC 2024-01-31 00841435121621 Tecomet TECOMET INC. HTC 2023-07-20 B356KJ526120 American Medicals American Medicals HTC 2022-12-14 14026704799135 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799142 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799159 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799166 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799319 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704799326 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 14026704811448 PILLING TELEFLEX INCORPORATED HTC 2022-12-08 10840199539830 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539847 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539854 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539861 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539878 Forceps KOROS U.S.A., INC. HTC 2022-10-31 10840199539885 Forceps KOROS U.S.A., INC. HTC 2022-10-31
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