Home GUDID 00818069011116 Tecomet
Primary DI 00818069011116
Brand Tecomet
Company TECOMET INC.
Model RS1021575
Device description 4.0mm A/O Screw Extractor
Published 2023-08-10
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 00818069011116 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 00818069011116 00818069011116 818069011116 0818069011116
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 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 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 00841435120365 Tecomet TECOMET INC. HWB 2022-10-03 00841435111226 Tecomet TECOMET INC. HWB 2020-10-09 00818069014858 Tecomet TECOMET INC. HWB 2020-10-09 00841435100688 Tecomet TECOMET INC. HWB 2020-10-09 00841435100695 Tecomet TECOMET INC. HWB 2020-10-09 00818069014339 Tecomet TECOMET INC. HWB 2020-08-20 00818069014346 Tecomet TECOMET INC. HWB 2020-08-20 00818069014353 Tecomet TECOMET INC. HWB 2020-08-20 00818069014360 Tecomet TECOMET INC. HWB 2020-08-07 00818069014377 Tecomet TECOMET INC. HWB 2020-08-07 00818069014384 Tecomet TECOMET INC. HWB 2020-08-07
tecomet.com