Pelvic Reconstruction Locking Plate 020280013

GUDID 06942782450038

Double Medical Technology Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID06942782450038
NIH Device Record Keyb7017c6f-dc54-4726-a968-82f76591a400
Commercial Distribution StatusIn Commercial Distribution
Brand NamePelvic Reconstruction Locking Plate
Version Model Number020280013
Catalog Number020280013
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
Phone+865926087101
Emailinfo@double-medical.com

Device Dimensions

Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0
Width10 Millimeter
Length154 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS106942782450038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

Moist Heat or Steam Sterilization


[06942782450038]

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 [Pelvic Reconstruction Locking Plate]

06942782450045020280014
06942782450038020280013
06942782407735020280012
06942782407728020280011
06942782407711020280010
06942782407704020280009
06942782407698020280008
06942782407681020280007
06942782407674020280006
06942782407667020280005
06942782407650020280004

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