RTS Surgical Instruments

GUDID 00817906020069

Flexible Great Toe Implant, surgical instruments

IN2BONES USA, LLC

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID00817906020069
NIH Device Record Keyca9a0757-3528-4410-bc75-51e1915385a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRTS Surgical Instruments
Version Model NumberM03 S0001
Company DUNS079700711
Company NameIN2BONES USA, LLC
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com
Phone901.260.7931
Emailinfo@i2b-usa.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100817906020069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWHProsthesis, Toe, Constrained, Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-11-05

On-Brand Devices [RTS Surgical Instruments]

00817906020069Flexible Great Toe Implant, surgical instruments
00817906020052Flexible Great Toe Implant, surgical instruments
00817906020045Flexible Great Toe Implant, surgical instruments

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