Calcaneal Locking Plate 020212075

GUDID 06942782405557

Double Medical Technology Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID06942782405557
NIH Device Record Key7aa963f3-ab87-4a25-b3ff-b13d03f2981e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalcaneal Locking Plate
Version Model Number020212075
Catalog Number020212075
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

Device Dimensions

Device Size Text, specify0
Length75 Millimeter
Width27.3 Millimeter
Device Size Text, specify0
Length75 Millimeter
Width27.3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS106942782405557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06942782405557]

Moist Heat or Steam Sterilization

[06942782405557]

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 [Calcaneal Locking Plate]

06942782405557020212075
06942782405540020212060
06942782405533020211075
06942782405526020211060
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