restor3d Guidewire

GUDID 00840097522708

Guidewire, Single Trocar, 1.6mm x 5"

Restor3d, Inc.

General internal orthopaedic fixation system implantation kit
Primary Device ID00840097522708
NIH Device Record Keyc7ca6faf-d1c8-45d9-b7d1-6a5b19abd3e1
Commercial Distribution StatusIn Commercial Distribution
Brand Namerestor3d Guidewire
Version Model Number6202-165
Company DUNS080819836
Company NameRestor3d, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097522708 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-30
Device Publish Date2025-05-22

Devices Manufactured by Restor3d, Inc.

00840097513744 - restor3d Anatomic Bone Model2025-05-30 Anatomic Bone Model
00840097522708 - restor3d Guidewire2025-05-30Guidewire, Single Trocar, 1.6mm x 5"
00840097522708 - restor3d Guidewire2025-05-30 Guidewire, Single Trocar, 1.6mm x 5"
00840097513782 - Ossera™ AFX2025-05-29 Cannulated Convex Reamer, Ø28
00840097517766 - Ossera™ AFX2025-05-29 Ossera™ AFX, Half Pill, 34x34
00840097517773 - Ossera™ AFX2025-05-29 Ossera™ AFX, Half Pill, 34x36
00840097517780 - Ossera™ AFX2025-05-29 Ossera™ AFX, Half Pill, 34x38
00840097517797 - Ossera™ AFX2025-05-29 Ossera™ AFX, Half Pill, 34x40
00840097517803 - Ossera™ AFX2025-05-29 Ossera™ AFX, Half Pill, 34x42

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