restor3d Reusable Instrument Tray/Kit

GUDID 00840097501338

Reusable Instrument Tray/Kit, Osteotomy Wedge System

Restor3d

Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID00840097501338
NIH Device Record Key94af4bc4-27dc-47d0-9345-0e7a5e046659
Commercial Distribution StatusIn Commercial Distribution
Brand Namerestor3d Reusable Instrument Tray/Kit
Version Model Number5000-0401K
Company DUNS080819836
Company NameRestor3d
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097501338 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


[00840097501338]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-24
Device Publish Date2019-12-16

Devices Manufactured by Restor3d

00840097509914 - restor3d Kinos Axiom PSR 2023-10-05 Axiom Talar PSR Chamfer-Cut
00840097509921 - restor3d Kinos Axiom PSR 2023-10-05 Axiom Talar PSR, Flat Cut
00840097509938 - restor3d Kinos Axiom PSR 2023-10-05 Kinos Axiom Coupled PSR, Chamfer-cut
00840097509945 - restor3d Kinos Axiom PSR 2023-10-05 Axiom coupled PSR, Flat-cut
00840097508900 - Kinos Axiom Instrumentation2023-07-27 50.5 mm x 1.21 mm Reciprocating Blade
00840097508917 - Kinos Axiom Instrumentation2023-07-27 90.0 mm x 12.7 mm x 1.26 mm Sagittal Blade
00840097507507 - Kinos Axiom Instrumentation2023-07-26 Talar Bone Mill, Size 1
00840097507514 - Kinos Axiom Instrumentation2023-07-26 Talar Bone Mill, Size 2/3

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