| Primary Device ID | 00841036036409 |
| NIH Device Record Key | 4aee6f99-6210-45be-bc5d-ce6b10883235 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TMJ SYSTEM |
| Version Model Number | 24-6532 |
| Catalog Number | 24-6532 |
| Company DUNS | 046189866 |
| Company Name | BIOMET MICROFIXATION, 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 |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM | |
| Phone | 904-741-4400 |
| FXJAX-ORDERS@BIOMET.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841036036409 [Primary] |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841036036409]
Moist Heat or Steam Sterilization
[00841036036409]
Moist Heat or Steam Sterilization
[00841036036409]
Moist Heat or Steam Sterilization
[00841036036409]
Moist Heat or Steam Sterilization
[00841036036409]
Moist Heat or Steam Sterilization
[00841036036409]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-17 |
| 00841036036379 | 2.0MM/ 2.7MM TMJ DOUBLE ENDED DRILL GUIDE |
| 00841036198121 | SP-1874-INT |
| 00841036155100 | SP-2896 |
| 00841036151348 | SP-1873-INT |
| 00841036147549 | 2.3X11MM FOSSA CROSS-DRIVE SCREW |
| 00841036140144 | 2.3X5MM FOSSA CROSS-DRIVE SCREW |
| 00841036138776 | 2.0X13MM FOSSA CROSS-DRIVE SCREW |
| 00841036134204 | SP-2328 |
| 00841036134198 | SP-2327 |
| 00841036129309 | INSTRUMENT TRAY |
| 00841036128692 | 2.0X5MM FOSSA CROSS-DRIVE SCREW |
| 00841036124991 | SCREW / TRIAL TRAY |
| 00841036081898 | 50 MM LEFT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT |
| 00841036081881 | 50 MM RIGHT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT |
| 00841036081874 | 45 MM LEFT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT |
| 00841036081867 | 45 MM RIGHT STANDARD OFFSET TITANIUM MANDIBULAR COMPONENT |
| 00841036081805 | 50 MM LEFT NARROW TITANIUM MANDIBULAR COMPONENT |
| 00841036081799 | 50 MM RIGHT NARROW TITANIUM MANDIBULAR COMPONENT |
| 00841036081782 | 45 MM LEFT NARROW TITANIUM MANDIBULAR COMPONENT |
| 00841036081744 | 55 MM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT |
| 00841036081737 | 50 MM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT |
| 00841036081720 | 50 MM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT |
| 00841036081713 | 45 MM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT |
| 00841036081560 | 45 MM LEFT STANDARD OFFSET MANDIBULAR COMPONENT |
| 00841036081553 | 45 MM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT |
| 00841036081386 | 45 MM RIGHT NARROW TITANIUM MANDIBULAR COMPONENT |
| 00841036081348 | 55 MM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT |
| 00841036075118 | 45 MM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT |
| 00841036064884 | 50 MM LEFT STANDARD OFFSET MANDIBULAR COMPONENT |
| 00841036063580 | 50 MM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT |
| 00841036060534 | TWIST DRILL WITH J-NOTCH 2.2X70,12STP |
| 00841036060428 | 50MM RIGHT STANDARD MANDIBULAR COMPONENT |
| 00841036060398 | 55 MM RIGHT STANDARD MANDIBULAR COMPONENT |
| 00841036060343 | 50 MM RIGHT STANDARD MANDIBULAR COMPONENT |
| 00841036060329 | 50 MM LEFT STANDARD MANDIBULAR COMPONENT |
| 00841036057480 | 2.3X9MM FOSSA CROSS-DRIVE SCREW |
| 00841036057473 | 2.3X7MM FOSSA CROSS-DRIVE SCREW |
| 00841036057466 | 2.0X11MM FOSSA CROSS-DRIVE SCREW |
| 00841036057459 | 2.0X9MM FOSSA CROSS-DRIVE SCREW |
| 00841036057442 | 2.0X7MM FOSSA CROSS-DRIVE SCREW |
| 00841036039271 | DINGMAN BONE HOLDING FORCEPS HEAVY PATTERN |
| 00841036039264 | DINGMAN BONE HOLDING FORCEPS LIGHT PATTERN |
| 00841036036683 | TWIST DRILL WITH J-NOTCH 2.2X115,12STP |
| 00841036036676 | TWIST DRILL WITH J-NOTCH 2.0X115,12STP |
| 00841036036669 | TWIST DRILL WITH J-NOTCH 2.0X70,12STP |
| 00841036036652 | TWIST DRILL WITH J-NOTCH 1.5X105,11 STP |
| 00841036036645 | TWIST DRILL WITH J-NOTCH 1.5X50,11 STP |
| 00841036036638 | LEFT FOSSA COMPONENT TRIAL LARGE |
| 00841036036621 | LEFT FOSSA COMPONENT, LARGE |
| 00841036036614 | RIGHT FOSSA COMPONENT TRIAL LARGE |