DISTRACTION, INTERNAL

GUDID 00888118113429

SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V

KLS-Martin L.P.

Implantable craniofacial bone distractor

• Primary Device ID: 00888118113429
• NIH Device Record Key: 989164a0-191b-4bb7-ab96-d6b7583016d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISTRACTION, INTERNAL
• Version Model Number: 50-348-05-61
• 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

Customer Support Contacts

• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888118113429 [Primary]

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00888118113429]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-09-23
• Device Publish Date: 2018-01-26

On-Brand Devices [DISTRACTION, INTERNAL]

• 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