Clavicular Reconstruction Locking Plate II, Curved 021592007

GUDID 06942782483524

Double Medical Technology Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID06942782483524
NIH Device Record Key5c776ef0-95bb-422f-89af-a3cb363faf87
Commercial Distribution StatusIn Commercial Distribution
Brand NameClavicular Reconstruction Locking Plate II, Curved
Version Model Number021592007
Catalog Number021592007
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

Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter
Device Size Text, specify0
Length107.5 Millimeter
Width10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS106942782483524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

Moist Heat or Steam Sterilization

[06942782483524]

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 [Clavicular Reconstruction Locking Plate II, Curved]

06942782483531021592008
06942782483524021592007
06942782483517021592006
06942782483500021591008
06942782483494021591007
06942782483487021591006
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