Universal End Cap for PFN/UFN/UTN 070080000

GUDID 06942782416232

Double Medical Technology Inc.

Tibia nail, non-sterile
Primary Device ID06942782416232
NIH Device Record Key2b20b430-6a66-487d-a811-0ab7833b9860
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal End Cap for PFN/UFN/UTN
Version Model Number070080000
Catalog Number070080000
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

Device Dimensions

Length14 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS106942782416232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06942782416232]

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

Devices Manufactured by Double Medical Technology Inc.

06902139111791 - Drill Guide for Guide Wire2020-04-06
06902139111982 - T-Handle with Quick Coupling2020-04-06
06902139112088 - Tissue Protector2020-04-06
06902139112125 - Insertion Handle2020-04-06
06902139111579 - Inserter-Extractor for Tibial Nail2019-04-23
06902139111807 - Connecting Screw for Inserter-Extractor2019-04-23
06902139111821 - Connecting Screw, for extracting nails2019-04-23
06902139111890 - Hammer Guide for Slide Hammer2019-04-23

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