Cannulated Reamer, 6.3mm, AO Quick Connect, Flex-Thread™

GUDID 00840118117678

Intramedullary fixation rod and accessories

FLOWER ORTHOPEDICS CORPORATION

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00840118117678
NIH Device Record Key7df07823-52e9-4ad3-a96e-6e8785b21da1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Reamer, 6.3mm, AO Quick Connect, Flex-Thread™
Version Model Number8527-1
Company DUNS078790947
Company NameFLOWER ORTHOPEDICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com
Phone+1(877)778-8587
Emailinfo@flowerortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118117678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

[00840118117678]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-29
Device Publish Date2021-03-19

On-Brand Devices [Cannulated Reamer, 6.3mm, AO Quick Connect, Flex-Thread™]

00840118117678Intramedullary fixation rod and accessories
00840118117425Intramedullary fixation rod and accessories
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