| Primary Device ID | 00888118136596 |
| NIH Device Record Key | 86ccbdd3-6411-43cd-ae0d-f87753e78eff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DISTRACTION, INTERNAL |
| Version Model Number | 25-025-43-07 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00888118136596 [Primary] |
| PBJ | Cranial Distraction System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
[00888118136596]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-02 |
| Device Publish Date | 2023-12-25 |
| 10888118094435 | PIN, DRILL FREE, TI-6AL-4V |
| 10888118094428 | PIN, DRILL FREE, TI-6AL-4V |
| 10888118007633 | SCREW, CROSSDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V |
| 10888118007619 | SCREW, CROSSDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V |
| 10888118007596 | SCREW, CROSSDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V |
| 10888118007572 | SCREW, CROSSDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V |
| 00888118117502 | DIST, MANDIBLE, HYPERDRIVE, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V |
| 00888118115447 | DIST, LEFORT 1, HYPERDRIVE, RIGHT, RTCH, 2.0-2.3 MM SCREW, TI-6AL-4V |
| 00888118115430 | DIST, LEFORT 1, HYPERDRIVE, LEFT, RTCH, 2.0-2.3 MM SCREW, TI-6AL-4V |
| 00888118113788 | PLATE, MODULAR, CRANIAL, NON SLIDING, 3 MM HOOKS, 1.5-1.8 MM SCREW, CP TITANIUM |
| 00888118113771 | PLATE, MODULAR, CRANIAL, SLIDING, 3 MM HOOKS, 1.5-1.8 MM SCREW, CP TITANIUM |
| 00888118113764 | PLATE, MODULAR, CRANIAL, NON SLIDING, 1.5-1.8 MM SCREW, CP TITANIUM |
| 00888118113757 | PLATE, MODULAR, CRANIAL, SLIDING, 1.5-1.8 MM SCREW, CP TITANIUM |
| 00888118113740 | DIST, ZURICH 2, MODULAR, END DRV, BODY ONLY, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V |
| 00888118113504 | DIST, LEFORT 1, ZURICH 2, RIGHT, RTCH, 4 MM BRG, 1.5-1.8 MM SCREW, TI-6AL-4V |
| 00888118113498 | DIST, LEFORT 1, ZURICH 2, LEFT, RTCH, 4 MM BRG, 1.5-1.8 MM SCREW, TI-6AL-4V |
| 00888118113443 | SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V |
| 00888118113436 | SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V |
| 00888118113429 | SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V |
| 00888118113412 | SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V |
| 00888118113405 | SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V |
| 00888118113399 | SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V |
| 00888118109491 | TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, TI-6AL-4V |
| 00888118109484 | PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 9 MM BRG, TI-6AL-4V |
| 00888118109477 | PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 6 MM BRG, TI-6AL-4V |
| 00888118109460 | PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 3 MM BRG, TI-6AL-4V |
| 00888118109453 | DIST, PALATAL, ROTTERDAM, 2.0-2.3 MM SCREW, TI-6AL-4V |
| 00888118108661 | DIST, MANDIBLE, HYPERDRIVE, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V |
| 00888118108036 | DIST, MANDIBLE, MICRO ZURICH 2, LYPKA, END DRV, 65*, RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V |
| 00888118106346 | DIST, LEFORT 3/MONO, MESH MIDFACE, END DRV, LEFT, BODY ONLY, 1.5-1.8 MM SCREW, TI-6AL-4V |
| 00888118106056 | TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, RIGHT, TI-6AL-4V |
| 00888118106049 | TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, RIGHT, TI-6AL-4V |
| 00888118106032 | TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, LEFT, TI-6AL-4V |
| 00888118106025 | TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, LEFT, TI-6AL-4V |
| 00888118103987 | DIST, PALATAL, ZURICH 2, TRANS, TLTS, RIGHT ANGLE, 2.0-2.3 MM SCREW, TI-6AL-4V |
| 00888118103949 | DIST, LEFORT 3/MONO, KAWAMOTO, M3, CVD, RIGHT, RTCH, DETACH, 1.5-1.8 MM SCREW, TI-6AL-4V |
| 00888118103932 | DIST, LEFORT 3/MONO, KAWAMOTO, M3, CVD, LEFT, RTCH, DETACH, 1.5-1.8 MM SCREW, TI-6AL-4V |
| 00888118103925 | DIST, MANDIBLE, HYPERDRIVE MICRO, RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V |
| 00888118102119 | DIST, CRANIAL, ZURICH 1, MID DRV, DETACH PLATES, MIDLINE, 1.5-1.8 MM SCREW, TI-6AL-4V |
| 00888118102003 | DIST, MANDIBLE, MICRO ZURICH 2, END DRV, RIGHT, OPP RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V |
| 00888118101990 | DIST, MANDIBLE, MICRO ZURICH 2, END DRV, LEFT, OPP RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V |
| 00888118101952 | DIST, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V |
| 00888118101945 | DIST, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V |
| 00888118101938 | DIST, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V |
| 00888118101914 | SCREW, CROSSDRIVE, TLTS TRANS, TI-6AL-4V |
| 00888118101907 | SCREW, CENTREDRIVE, TLTS TRANS, TI-6AL-4V |
| 00888118101402 | ACT ARM, RIGID, REMOTE DETACH, CONCEALED TIP, TI-6AL-4V |
| 00888118101396 | DIST, LEFORT 3/MONO, KAWAMOTO, STAFFENBERG, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V |
| 00888118101372 | PLATE, CONSOLIDATION, FOR RAMUS TRANSPORT DEVICE, 1.5 MM SCREW, CP TITANIUM |
| 00888118101228 | DIST, LEFORT 1, ZURICH TELE, RIGHT, 40 MM POSTERIOR BAR, 2.0-2.3 MM SCREW, TI-6AL-4V |