| Primary Device ID | 00811687031375 |
| NIH Device Record Key | d8b73db0-ca1b-4dba-91e2-505b6a9d715f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MCI - Medical Concept Innovation, Inc. |
| Version Model Number | A01.01.1345 |
| Catalog Number | A01.01.1345 |
| Company DUNS | 080815653 |
| Company Name | MCI-MEDICAL CONCEPT INNOVATION INC |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811687031375 [Primary] |
| JEY | Plate, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
[00811687031375]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-07 |
| Device Publish Date | 2022-10-28 |
| 00811687031665 | CADDY LID FOR PLATE 1.5 |
| 00811687031658 | CADDY LID FOR PLATE 2.0 |
| 00811687031580 | TRANSBUCCAL HANDLE |
| 00811687031573 | MCI SYSTEM CASE |
| 00811687031535 | CADDY BASE FOR PLATE 1.5 |
| 00811687031528 | CADDY BASE FOR PLATE 2.0 |
| 00811687031511 | DRILL 1.5 X 100MM WITH STOP 20MM |
| 00811687031504 | DRILL 1.5 X 100MM WITH STOP 5MM |
| 00811687031498 | DRILL 1.5 X 50MM WITH STOP 20MM |
| 00811687031481 | DRILL 1.5 X 50MM WITH STOP 5MM |
| 00811687031474 | SCREWDRIVER MANIPULATION TIP LOCKING 2.0 |
| 00811687031467 | DRILL 1.1 X 50MM WITH STOP 5MM |
| 00811687031450 | DRILL 1.1 X 50MM WITH STOP 20MM |
| 00811687031443 | DRILL 1.1 X 100MM WITH STOP 5MM |
| 00811687031436 | DRILL 1.1 X 100MM WITH STOP 20MM |
| 00811687031429 | AUTO DRIVE SCREW N 1.5 X 4MM |
| 00811687031412 | STRAIGHT MICRO PLATE N BRIDGE 7MM 2H |
| 00811687031405 | L OBLIQUE ORBITAL MICRO PLATE BRIDGE 10MM #0.6 LEFT |
| 00811687031399 | L OBLIQUE MICRO PLATE BRIDGE 10MM #0.6 RIGHT |
| 00811687031382 | SUPPORT ZYGOMATIC MICRO PLATE LEFT |
| 00811687031375 | SUPPORT ZYGOMATIC MICRO PLATE RIGHT |
| 00811687031368 | STAR MICRO MESH 51.1X52.7 #0.2MM |
| 00811687031351 | 10° BSSO DUAL ANGLED MINI PLATE BRIDGE 10.5MM DF |
| 00811687031344 | 10° BSSO DUAL ANGLED MINI PLATE BRIDGE 13.5MM DF |
| 00811687031337 | 10° BSSO DUAL ANGLED MINI PLATE BRIDGE 16.5MM DF |
| 00811687031320 | SAGITTAL MINI PLATE CUT OBLONG BRIDGE 15MM |
| 00811687031306 | L MICRO PLATE BRIDGE 6MM 4H RIGHT |
| 00811687031207 | SCREWDRIVER MANIPULATION TIP 2.0 |
| 00811687031191 | SCREWDRIVER MANIPULATION TIP 1.5 |
| 00811687031184 | SCREWDRIVER MANIPULATION TIP 2.0 - SHORT |
| 00811687031177 | SCREWDRIVER MANIPULATION TIP 1.5 - SHORT |
| 00811687031160 | BENDING PLIERS 1.5 - 2.0 |
| 00811687031153 | DRILLING GUIDE 1.5 - 2.0 |
| 00811687031146 | DEPTH GAUGE CMF |
| 00811687031115 | MODELING PLIERS 2.0 |
| 00811687031108 | MODELING PLIERS 1.5 |
| 00811687031092 | SCREWDRIVER GUIDE ADAPTER 1,5 - 2.0 |
| 00811687031085 | PUNCHER |
| 00811687031078 | DRILL GUIDE 1,5 - 2,0 |
| 00811687031061 | SCREWDRIVER HANDLE |
| 00811687031054 | RETRACTOR CHEEK OF TRANSBUCCAL |
| 00811687031047 | SLIM TRANSBUCCAL HANDLE |
| 00811687031023 | LOCKING SCREW AP 12 X 0 TI CROSS DRIVE |
| 00811687031016 | LOCKING SCREW AP 10 X 0 TI CROSS DRIVE |
| 00811687031009 | LOCKING SCREW AP 8 X 0 TI CROSS DRIVE |
| 00811687030996 | LOCKING SCREW AP 6 X 0 TI CROSS DRIVE |
| 00811687030989 | STRAIGHT MICRO PLATE 6H |
| 00811687030804 | T MINI PLATE 6H |
| 00811687030774 | STRAIGHT MINI PLATE BRIDGE 9MM 6H |
| 00811687030767 | STRAIGHT MINI PLATE BRIDGE 13,5MM 4H |