Home GUDID 00818069014407 Tecomet
Primary DI 00818069014407
Brand Tecomet
Company TECOMET INC.
Model RS1021378
Device description 3.5mm A/O Screw Extractor
Published 2020-08-07
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 HWB Extractor
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWB Extractor Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00818069014407 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00818069014407 00818069014407 818069014407 0818069014407
GMDN Terms# Term, Definition table Term Definition Orthopaedic inorganic implant inserter/extractor, reusable A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 078749695 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 true 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 00810017915804 SABER-XA, Height Expander ELEVATION SPINE, INC. HWB 2026-08-14 00810017915811 SABER-XA, Lordosis Expander ELEVATION SPINE, INC. HWB 2026-08-14 00810017915958 Slap Hammer ELEVATION SPINE, INC. HWB 2026-08-14 00810017915965 Slap Hammer Adaptor ELEVATION SPINE, INC. HWB 2026-08-14 03701089527965 AMPLITUDE AMPLITUDE SAS HWB 2026-07-29 03701089527972 AMPLITUDE AMPLITUDE SAS HWB 2026-07-29 03701089531276 AMPLITUDE AMPLITUDE SAS HWB 2026-07-29 00889024711495 Z1 Extractor Zimmer, Inc. HWB 2026-07-20 08800068946966 BENCOX Corentec Co., Ltd HWB 2026-07-01 08800068946973 BENCOX Corentec Co., Ltd HWB 2026-07-01 08800068963666 BENCOX Corentec Co., Ltd HWB 2026-07-01 08806373897344 BENCOX Corentec Co., Ltd HWB 2026-07-01 08806373897351 BENCOX Corentec Co., Ltd HWB 2026-07-01 08806373897368 BENCOX Corentec Co., Ltd HWB 2026-07-01 08806373897375 BENCOX Corentec Co., Ltd HWB 2026-07-01 08806373897382 BENCOX Corentec Co., Ltd HWB 2026-07-01 10603295543695 ATTUNE DEPUY (IRELAND) HWB 2025-10-31 00810135963411 Impact NVision Biomedical Technologies, Inc. HWB 2025-09-24 00840314269737 gSource GSOURCE LLC HWB 2025-05-05 00885556820964 General Instruments Smith & Nephew, Inc. HWB 2023-10-27 00818069011031 Tecomet TECOMET INC. HWB 2023-08-10 00818069011048 Tecomet TECOMET INC. HWB 2023-08-10 00818069011055 Tecomet TECOMET INC. HWB 2023-08-10 00818069011062 Tecomet TECOMET INC. HWB 2023-08-10 00818069011079 Tecomet TECOMET INC. HWB 2023-08-10 00818069011086 Tecomet TECOMET INC. HWB 2023-08-10 00818069011093 Tecomet TECOMET INC. HWB 2023-08-10 00818069011109 Tecomet TECOMET INC. HWB 2023-08-10 00818069011116 Tecomet TECOMET INC. HWB 2023-08-10 00841435120365 Tecomet TECOMET INC. HWB 2022-10-03
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