Distal Radius Plate, Volar (L), 11 Holes

GUDID 00840118104005

Compatible with 2.7mm/3.5mm, implants for orthopedic bone fixation

FLOWER ORTHOPEDICS CORPORATION

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device ID00840118104005
NIH Device Record Key676786e6-78f7-4028-ab06-77f350c5a502
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Radius Plate, Volar (L), 11 Holes
Version Model NumberFRP 445
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
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com
Phone8777788587
Emailinfo@flowerortho.com

Device Dimensions

Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840118104005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

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 Date2015-09-15

Devices Manufactured by FLOWER ORTHOPEDICS CORPORATION

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00840118124768 - Flower Orthopedics2024-12-25 OsteoCoil Nitinol Compression System- 7.3mm x 95mm
00840118124836 - Flower Orthopedics2024-12-25 OsteoCoil Nitinol Compression System- 7.3mm x 130mm
00840118124102 - Flower Orthopedics2024-12-12 OsteoCoil Nitinol Compression System- 4.5mm x 40mm
00840118124119 - Flower Orthopedics2024-12-12 OsteoCoil Nitinol Compression System- 4.5mm x 45mm

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