Flower E-Kit, Advanced

GUDID 00840118112079

surgical instrument or accessory for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic bone wire Orthopaedic bone wire
Primary Device ID00840118112079
NIH Device Record Keyc7716e47-d63c-44b7-a4fa-ef088a09e57c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlower E-Kit, Advanced
Version Model NumberEWK 201
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 Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118112079 [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 StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-02

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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