| Primary Device ID | 00888118101129 |
| NIH Device Record Key | 906daf5b-51f7-4384-9e31-5738820bdf88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DISTRACTION, EXTERNAL |
| Version Model Number | 99-059-23-02 |
| Company DUNS | 826499238 |
| Company Name | KLS-Martin L.P. |
| 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 | false |
| 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 | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com | |
| Phone | +1(904)641-7746 |
| KLS-UDI-Info@klsmartin.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888118101129 [Primary] |
| MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
[00888118101129]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-09-23 |
| Device Publish Date | 2016-07-28 |
| 10888118099621 | SPINDLE, RED 2, SLEEK, ADJ, STAINLESS STEEL |
| 10888118083385 | PIN, DRILL FREE, TI-6AL-4V |
| 10888118083378 | PIN, DRILL FREE, TI-6AL-4V |
| 10888118083361 | PIN, DRILL FREE, TI-6AL-4V |
| 10888118083354 | PIN, DRILL FREE, TI-6AL-4V |
| 10888118083347 | PIN, DRILL FREE, TI-6AL-4V |
| 10888118082289 | SCREW, HEX, RED 2, HALO FIXATION, SMOOTH, SILVER, CP TITANIUM |
| 10888118082265 | SCREW, HEX, RED 2, HALO FIXATION, SMOOTH, SILVER, CP TITANIUM |
| 00888118121752 | LOCK NUT, 3DX, GORDON, TI-6AL-4V |
| 00888118113481 | CLAMP, 3DX, PIN HOLDING W/SET SCREW, TI-6AL-4V |
| 00888118113474 | DIST, MANDIBLE, 3DX, GORDON, 2.0-2.7 MM PIN, TI-6AL-4V |
| 00888118108593 | PLATE, RED 2, MIDFACE FIXATION, V SHP, 1.5-1.8 MM SCREW, CP TITANIUM |
| 00888118108463 | SCREW, HEX, RED 2, HALO FIXATON, DRILL FREE, HOPPER, SMOOTH, SILVER, CP TITANIUM |
| 00888118108456 | SCREW, HEX, RED 2, HALO FIXATON, DRILL FREE, HOPPER, SMOOTH, SILVER, CP TITANIUM |
| 00888118108029 | PIN, DRILL FREE, TI-6AL-4V |
| 00888118108012 | PIN, DRILL FREE, TI-6AL-4V |
| 00888118108005 | PIN, DRILL FREE, TI-6AL-4V |
| 00888118107992 | PIN, DRILL FREE, TI-6AL-4V |
| 00888118107985 | PIN, DRILL FREE, TI-6AL-4V |
| 00888118103970 | PLATE, RED 2, MIDFACE FIXATION, BURTON, 1.5-1.8 MM SCREW, CP TITANIUM |
| 00888118102126 | HORIZONTAL CROSS BAR ASSEMBLY, RED 2, COMPLETE, BLACK, ALUMINUM / STAINLESS STEEL |
| 00888118102102 | SEGMENT, RED 3, RIGHT, ALUMINUM |
| 00888118102096 | SEGMENT, RED 3, LEFT, ALUMINUM |
| 00888118102089 | HORIZONTAL CROSS BAR, RED 3, CARBON |
| 00888118102058 | HOLDER, RED 2, FOR HORIZONTAL CROSS BAR, BLACK, ALUMINUM |
| 00888118102041 | UPPER PART, RED 2, BLACK, ALUMINUM |
| 00888118102034 | SEGMENT, RED 2, RIGHT, BLACK, ALUMINUM |
| 00888118102027 | SEGMENT, RED 2, LEFT, BLACK, ALUMINUM |
| 00888118102010 | SPINDLE, RED 2, SLEEK, ADJ, STAINLESS STEEL |
| 00888118101129 | LOCK NUT, 3DX, GORDON, TI-6AL-4V |
| 00888118099891 | PLATE, RED 2, RETENTION, STURMAN, T LONG, 90*, W/GROOVE, 1.5-1.8 MM SCREW, STAINLESS STEEL ASTM |
| 00888118099860 | HORIZONTAL CROSS BAR, RED 2, HOLLOW, STAINLESS STEEL |
| 00888118099846 | DIST, RED 3, PEDIATRIC, SILVER, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:00888118102096 |
| 00888118099839 | DIST, RED 2, ROUNDED FIXATION, PURPLE, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:0088811 |
| 00888118099822 | DIST, RED 2, PURPLE, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:00888118082312, 008881180 |
| 00888118099815 | DIST, RED 2, GREEN, LESS SCREWS AND O/R SCREWDRIVER |
| 00888118099808 | DIST, RED 2, GOLD, LESS SCREWS & O/R SCREWDRIVER |
| 00888118099792 | DIST, RED 2, RED, LESS SCREWS & O/R SCREWDRIVER |
| 00888118099785 | DIST, RED 2, SILVER, LESS SCREWS AND O/R SCREWDRIVER |
| 00888118099778 | DIST, RED 2, BLACK, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:00888118102027, 008881181 |
| 00888118099723 | DIST, RED 2, ROUNDED FIXATION, PURPLE, LESS SCREWS AND O/R SCREWDRIVER |
| 00888118095244 | SCREW, HEX, RED 2, TRIAL POSITIONING, KNURLED, FOR HALO, BLUE, TI-6AL-4V |
| 00888118095206 | PLATE, RED 2, TLTS, RETENTION, T LONG, S CVD, 2.0-2.3 MM SCREW, TI-6AL-4V |
| 00888118093363 | PLATE, RED 2, TLTS, RETENTION, T LONG, 2 BAR, 2.0-2.3 MM SCREW, TI-6AL-4V |
| 00888118093141 | LOCK NUT, 3DX, GORDON, TI-6AL-4V |
| 00888118093097 | SCREW, HEX, RED 2, HALO FIXATION, DRILL FREE, HOPPER, SMOOTH, SILVER, CP TITANIUM |
| 00888118092861 | DIST, MANDIBLE, MOLINA, BIDIRECT, RIGHT, 3.2 MM PIN, TI-6AL-4V |
| 00888118092854 | DIST, MANDIBLE, MOLINA, BIDIRECT, RIGHT, 2.7 MM PIN, TI-6AL-4V |
| 00888118092847 | DIST, MANDIBLE, MOLINA, BIDIRECT, LEFT, 2.7 MM PIN, TI-6AL-4V |
| 00888118092830 | DIST, MANDIBLE, MOLINA, BIDIRECT, LEFT, 2.7 MM PIN, TI-6AL-4V |