Fixation Sleeve for Drill Bit Φ4.0 110302300

GUDID 06902139111647

Double Medical Technology Inc.

Orthopaedic implantation sleeve, reusable
Primary Device ID06902139111647
NIH Device Record Keyc58fb45e-1feb-4c75-9c8c-72b3c86e2c50
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixation Sleeve for Drill Bit Φ4.0
Version Model Number110302300
Catalog Number110302300
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS106902139111647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06902139111647]

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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