Radian MIS Bunion System

GUDID 00810005665704

5.0mm Correction L-Bunion Plate. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00810005665704
NIH Device Record Keya378efa2-7819-4283-bcc1-942c4affc377
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadian MIS Bunion System
Version Model NumberBUN-PLT-05
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com

Device Dimensions

Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810005665704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

[00810005665704]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-09
Device Publish Date2022-02-01

On-Brand Devices [Radian MIS Bunion System]

00810005667852Tray: MIS Bunion K-Wire Tube. The Radian MIS Bunion System is intended for fixation of osteoto
00810005667845Tray: MIS Bunion Caddy Lid. The Radian MIS Bunion System is intended for fixation of osteotomi
00810005667838Tray: MIS Bunion Caddy Base. The Radian MIS Bunion System is intended for fixation of osteotom
00810005667821Tray: MIS Bunion Tray Lid. The Radian MIS Bunion System is intended for fixation of osteotomie
00810005667814Tray: MIS Bunion Tray Base. The Radian MIS Bunion System is intended for fixation of osteotomi
00810005663861Instrument: Small Olive Pin. The Radian MIS Bunion System is intended for fixation of osteotom
00810005663854Instrument: Depth Gauge tool. The Radian MIS Bunion System is intended for fixation of osteoto
00810005663847Instrument: Olive Pin. The Radian MIS Bunion System is intended for fixation of osteotomies an
00810005663830Instrument: 3.0mm Diameter Drill. The Radian MIS Bunion System is intended for fixation of ost
00810005663823Instrument: Drill Guide. The Radian MIS Bunion System is intended for fixation of osteotomies
008100056657045.0mm Correction L-Bunion Plate. The Radian MIS Bunion System is intended for fixation of osteo
008100056693443.0mm Correction L-Bunion Plate. The Radian MIS Bunion System is intended for fixation of osteo
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