MCI - Medical Concept Innovation, Inc. A01.02.1105

GUDID 00811687031948

X MICRO PLATE N BRIDGE 9MM

MCI-MEDICAL CONCEPT INNOVATION INC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00811687031948
NIH Device Record Key2887d970-72ef-426a-a88f-615996e94de8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMCI - Medical Concept Innovation, Inc.
Version Model NumberA01.02.1105
Catalog NumberA01.02.1105
Company DUNS080815653
Company NameMCI-MEDICAL CONCEPT INNOVATION INC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com
Phone19543062521
Emailcustomer.service@mci-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811687031948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPlate, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


[00811687031948]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-22
Device Publish Date2023-06-14

On-Brand Devices [MCI - Medical Concept Innovation, Inc.]

00811687031665CADDY LID FOR PLATE 1.5
00811687031658CADDY LID FOR PLATE 2.0
00811687031580TRANSBUCCAL HANDLE
00811687031573MCI SYSTEM CASE
00811687031535CADDY BASE FOR PLATE 1.5
00811687031528CADDY BASE FOR PLATE 2.0
00811687031511DRILL 1.5 X 100MM WITH STOP 20MM
00811687031504DRILL 1.5 X 100MM WITH STOP 5MM
00811687031498DRILL 1.5 X 50MM WITH STOP 20MM
00811687031481DRILL 1.5 X 50MM WITH STOP 5MM
00811687031474SCREWDRIVER MANIPULATION TIP LOCKING 2.0
00811687031467DRILL 1.1 X 50MM WITH STOP 5MM
00811687031450DRILL 1.1 X 50MM WITH STOP 20MM
00811687031443DRILL 1.1 X 100MM WITH STOP 5MM
00811687031436DRILL 1.1 X 100MM WITH STOP 20MM
00811687031429AUTO DRIVE SCREW N 1.5 X 4MM
00811687031412STRAIGHT MICRO PLATE N BRIDGE 7MM 2H
00811687031405L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.6 LEFT
00811687031399L OBLIQUE MICRO PLATE BRIDGE 10MM #0.6 RIGHT
00811687031382SUPPORT ZYGOMATIC MICRO PLATE LEFT
00811687031375SUPPORT ZYGOMATIC MICRO PLATE RIGHT
00811687031368STAR MICRO MESH 51.1X52.7 #0.2MM
0081168703135110° BSSO DUAL ANGLED MINI PLATE BRIDGE 10.5MM DF
0081168703134410° BSSO DUAL ANGLED MINI PLATE BRIDGE 13.5MM DF
0081168703133710° BSSO DUAL ANGLED MINI PLATE BRIDGE 16.5MM DF
00811687031320SAGITTAL MINI PLATE CUT OBLONG BRIDGE 15MM
00811687031306L MICRO PLATE BRIDGE 6MM 4H RIGHT
00811687031207SCREWDRIVER MANIPULATION TIP 2.0
00811687031191SCREWDRIVER MANIPULATION TIP 1.5
00811687031184SCREWDRIVER MANIPULATION TIP 2.0 - SHORT
00811687031177SCREWDRIVER MANIPULATION TIP 1.5 - SHORT
00811687031160BENDING PLIERS 1.5 - 2.0
00811687031153DRILLING GUIDE 1.5 - 2.0
00811687031146DEPTH GAUGE CMF
00811687031115MODELING PLIERS 2.0
00811687031108MODELING PLIERS 1.5
00811687031092SCREWDRIVER GUIDE ADAPTER 1,5 - 2.0
00811687031085PUNCHER
00811687031078DRILL GUIDE 1,5 - 2,0
00811687031061SCREWDRIVER HANDLE
00811687031054RETRACTOR CHEEK OF TRANSBUCCAL
00811687031047SLIM TRANSBUCCAL HANDLE
00811687031023LOCKING SCREW AP 12 X 0 TI CROSS DRIVE
00811687031016LOCKING SCREW AP 10 X 0 TI CROSS DRIVE
00811687031009LOCKING SCREW AP 8 X 0 TI CROSS DRIVE
00811687030996LOCKING SCREW AP 6 X 0 TI CROSS DRIVE
00811687030989STRAIGHT MICRO PLATE 6H
00811687030804T MINI PLATE 6H
00811687030774STRAIGHT MINI PLATE BRIDGE 9MM 6H
00811687030767STRAIGHT MINI PLATE BRIDGE 13,5MM 4H

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