Inserter Draw Rod, Flex-Thread™

GUDID 00840118117555

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 ID00840118117555
NIH Device Record Key5ae99dd3-34d8-4542-8aa1-dd63ce4b6f39
Commercial Distribution StatusIn Commercial Distribution
Brand NameInserter Draw Rod, Flex-Thread™
Version Model Number8439-1
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
GS100840118117555 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

Moist Heat or Steam Sterilization

[00840118117555]

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

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

00840118119610 - Flower Orthopedics2024-04-15 Screw Washer- For 2.7/3.5/4.0 Screws, 10mm
00840118119634 - Flower Orthopedics2024-04-15 2.7mm x 8mm Locking Screw
00840118119641 - Flower Orthopedics2024-04-15 2.7mm x 10mm Locking Screw
00840118119658 - Flower Orthopedics2024-04-15 2.7mm x 12mm Locking Screw
00840118119665 - Flower Orthopedics2024-04-15 2.7mm x 14mm Locking Screw
00840118119672 - Flower Orthopedics2024-04-15 2.7mm x 16mm Locking Screw
00840118119689 - Flower Orthopedics2024-04-15 2.7mm x 18mm Locking Screw
00840118119696 - Flower Orthopedics2024-04-15 2.7mm x 20mm Locking Screw
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