restor3d Reusable Instrument Tray/Kit

GUDID 00840097501338

Reusable Instrument Tray/Kit, Osteotomy Wedge System

Restor3d

Sterilization/disinfection container

Primary Device ID	00840097501338
NIH Device Record Key	94af4bc4-27dc-47d0-9345-0e7a5e046659
Commercial Distribution Status	In Commercial Distribution
Brand Name	restor3d Reusable Instrument Tray/Kit
Version Model Number	5000-0401K
Company DUNS	080819836
Company Name	Restor3d
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097501338 [Primary]

FDA Product Code

MDM	Instrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[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 Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-12-24
Device Publish Date	2019-12-16

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 Instrumentation	2023-07-27 50.5 mm x 1.21 mm Reciprocating Blade
00840097508917 - Kinos Axiom Instrumentation	2023-07-27 90.0 mm x 12.7 mm x 1.26 mm Sagittal Blade
00840097507507 - Kinos Axiom Instrumentation	2023-07-26 Talar Bone Mill, Size 1
00840097507514 - Kinos Axiom Instrumentation	2023-07-26 Talar Bone Mill, Size 2/3

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