Proximal Humeral Locking Plate I, Combi-holes 020390005

GUDID 06942782481827

Double Medical Technology Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID06942782481827
NIH Device Record Keyf9fb0bb6-7943-4cac-9218-986ae9a3a840
Commercial Distribution StatusIn Commercial Distribution
Brand NameProximal Humeral Locking Plate I, Combi-holes
Version Model Number020390005
Catalog Number020390005
Company DUNS529366055
Company NameDouble Medical Technology Inc.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com

Device Dimensions

Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length141.1 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS106942782481827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


[06942782481827]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [Proximal Humeral Locking Plate I, Combi-holes]

06942782481872020390010
06942782481865020390009
06942782481858020390008
06942782481841020390007
06942782481834020390006
06942782481827020390005
06942782481810020390004
06942782481803020390003

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.