Home GUDID 00850018366007 Tailored-C
Primary DI 00850018366007
Brand Tailored-C
Company BESPOKE TECHNOLOGIES, LLC
Model BCI-001
Device description ANTERIOR CERVICAL 3DTI INSERTER
Published 2025-03-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name ODP Intervertebral Fusion Device With Bone Graft, Cervical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850018366007 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 00850018366007 00850018366007 850018366007 0850018366007
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 056684302 Device count 1 Premarket exempt true Lot or batch true 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 00810017915125 SABER-XA, Screw Ø5.0 x 22.5 ELEVATION SPINE, INC. ODP 2026-09-22 00810017915149 SABER-XA, Screw Ø5.0 x 32.5 ELEVATION SPINE, INC. ODP 2026-09-22 00810017915156 SABER-XA, Screw Ø5.5 x 22.5 ELEVATION SPINE, INC. ODP 2026-09-22 00810017915163 SABER-XA, Screw Ø5.5 x 27.5 ELEVATION SPINE, INC. ODP 2026-09-22 07613327503968 Aero-C Stryker Corporation ODP 2019-12-18 10888857461819 CASCADIA™ Interbody System VB Spine LLC ODP 2019-10-31 10888857461888 CASCADIA™ Interbody System VB Spine LLC ODP 2019-10-31 07613327353921 Aero-C Stryker Corporation ODP 2018-06-28 07613327353938 Aero-C Stryker Corporation ODP 2018-06-28 07613327353945 Aero-C Stryker Corporation ODP 2018-06-28 07613327353952 Aero-C Stryker Corporation ODP 2018-06-28 07613327353976 Aero-C Stryker Corporation ODP 2018-06-28 07613327347036 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347050 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347067 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347098 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347159 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347197 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347296 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347333 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347357 Tritanium C Stryker Corporation ODP 2017-09-18 07613327347364 Tritanium C Stryker Corporation ODP 2017-09-18 07613327349535 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360035 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360103 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360257 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360363 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360370 Tritanium C Stryker Corporation ODP 2017-09-18 07613327360516 Tritanium C Stryker Corporation ODP 2017-09-18 07613252602774 AVS Anchor-L Stryker Corporation ODP 2016-09-24