Home GUDID B014FOWL08 Osteotomy Wedge
Primary DI B014FOWL08
Brand Osteotomy Wedge
Company EMINENT SPINE LLC
Model FOWL08
Published 2017-02-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name HRS Plate, Fixation, Bone HWC Screw, Fixation, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRS Plate, Fixation, Bone Orthopedic 2 HWC Screw, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B014FOWL08 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition External orthopaedic fixation system, single-use, non-sterile An assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 022576742 Device count 1 Lot or batch true Manufacturing date on label 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 00885556836187 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836163 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836170 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836194 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836200 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836217 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836224 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836248 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836255 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836262 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835999 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836002 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836019 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836026 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836033 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836040 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836057 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836064 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836071 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836088 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836095 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836118 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836125 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836132 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836149 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836156 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556838785 Total Foot System 2 Smith & Nephew, Inc. HRS 2022-12-21 00885556838785 Total Foot System 2 Smith & Nephew, Inc. HWC 2022-12-21 00888867007475 Arthrex® ARTHREX, INC. HRS 2017-02-15 00888867007499 Arthrex® ARTHREX, INC. HRS 2017-02-15