K-Wire Kit, Medium

GUDID 00840118103657

surgical instrument or accessory for orthopedic bone fixation, kit includes k-wires (2), screwdriver, depth gauge

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone wire
Primary Device ID00840118103657
NIH Device Record Keyb019c276-1b0e-42a2-a597-ccba467999d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-Wire Kit, Medium
Version Model NumberKWK 002
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118103657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPin, Fixation, Smooth

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-22

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

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00840118125475 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 29mm
00840118125482 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 30mm
00840118125499 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 31mm
00840118125505 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 32mm
00840118125512 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 33mm
00840118125529 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 34mm
00840118125536 - Flower Orthopedics2024-09-02 4.0mm Cannulated Headed Screw, 35mm

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