DISTRACTION, INTERNAL

GUDID 00888118127761

DIST, LEFORT 1, ZURICH TELE, LEFT, 40 MM POSTERIOR BAR, 2.0-2.3 MM SCREW, TI-6AL-4V

KLS-Martin L.P.

Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor
Primary Device ID00888118127761
NIH Device Record Keyccf1609a-866f-4168-b529-363aa6079733
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISTRACTION, INTERNAL
Version Model Number51-360-40-09
Company DUNS826499238
Company NameKLS-Martin L.P.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]
GS100888118127761 [Primary]

FDA Product Code

MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


[00888118127761]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [DISTRACTION, INTERNAL]

10888118094435PIN, DRILL FREE, TI-6AL-4V
10888118094428PIN, DRILL FREE, TI-6AL-4V
10888118007633SCREW, CROSSDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
10888118007619SCREW, CROSSDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
10888118007596SCREW, CROSSDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
10888118007572SCREW, CROSSDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
00888118117502DIST, MANDIBLE, HYPERDRIVE, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
00888118115447DIST, LEFORT 1, HYPERDRIVE, RIGHT, RTCH, 2.0-2.3 MM SCREW, TI-6AL-4V
00888118115430DIST, LEFORT 1, HYPERDRIVE, LEFT, RTCH, 2.0-2.3 MM SCREW, TI-6AL-4V
00888118113788PLATE, MODULAR, CRANIAL, NON SLIDING, 3 MM HOOKS, 1.5-1.8 MM SCREW, CP TITANIUM
00888118113771PLATE, MODULAR, CRANIAL, SLIDING, 3 MM HOOKS, 1.5-1.8 MM SCREW, CP TITANIUM
00888118113764PLATE, MODULAR, CRANIAL, NON SLIDING, 1.5-1.8 MM SCREW, CP TITANIUM
00888118113757PLATE, MODULAR, CRANIAL, SLIDING, 1.5-1.8 MM SCREW, CP TITANIUM
00888118113740DIST, ZURICH 2, MODULAR, END DRV, BODY ONLY, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
00888118113504DIST, LEFORT 1, ZURICH 2, RIGHT, RTCH, 4 MM BRG, 1.5-1.8 MM SCREW, TI-6AL-4V
00888118113498DIST, LEFORT 1, ZURICH 2, LEFT, RTCH, 4 MM BRG, 1.5-1.8 MM SCREW, TI-6AL-4V
00888118113443SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
00888118113436SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
00888118113429SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
00888118113412SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
00888118113405SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
00888118113399SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
00888118109491TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, TI-6AL-4V
00888118109484PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 9 MM BRG, TI-6AL-4V
00888118109477PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 6 MM BRG, TI-6AL-4V
00888118109460PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 3 MM BRG, TI-6AL-4V
00888118109453DIST, PALATAL, ROTTERDAM, 2.0-2.3 MM SCREW, TI-6AL-4V
00888118108661DIST, MANDIBLE, HYPERDRIVE, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
00888118108036DIST, MANDIBLE, MICRO ZURICH 2, LYPKA, END DRV, 65*, RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
00888118106346DIST, LEFORT 3/MONO, MESH MIDFACE, END DRV, LEFT, BODY ONLY, 1.5-1.8 MM SCREW, TI-6AL-4V
00888118106056TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, RIGHT, TI-6AL-4V
00888118106049TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, RIGHT, TI-6AL-4V
00888118106032TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, LEFT, TI-6AL-4V
00888118106025TUBE, LEFORT 1, ADJ MIDFACE, BUTTRESS, ADJ LENGTH, LEFT, TI-6AL-4V
00888118103987DIST, PALATAL, ZURICH 2, TRANS, TLTS, RIGHT ANGLE, 2.0-2.3 MM SCREW, TI-6AL-4V
00888118103949DIST, LEFORT 3/MONO, KAWAMOTO, M3, CVD, RIGHT, RTCH, DETACH, 1.5-1.8 MM SCREW, TI-6AL-4V
00888118103932DIST, LEFORT 3/MONO, KAWAMOTO, M3, CVD, LEFT, RTCH, DETACH, 1.5-1.8 MM SCREW, TI-6AL-4V
00888118103925DIST, MANDIBLE, HYPERDRIVE MICRO, RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
00888118102119DIST, CRANIAL, ZURICH 1, MID DRV, DETACH PLATES, MIDLINE, 1.5-1.8 MM SCREW, TI-6AL-4V
00888118102003DIST, MANDIBLE, MICRO ZURICH 2, END DRV, RIGHT, OPP RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
00888118101990DIST, MANDIBLE, MICRO ZURICH 2, END DRV, LEFT, OPP RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
00888118101952DIST, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V
00888118101945DIST, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V
00888118101938DIST, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V
00888118101914SCREW, CROSSDRIVE, TLTS TRANS, TI-6AL-4V
00888118101907SCREW, CENTREDRIVE, TLTS TRANS, TI-6AL-4V
00888118101402ACT ARM, RIGID, REMOTE DETACH, CONCEALED TIP, TI-6AL-4V
00888118101396DIST, LEFORT 3/MONO, KAWAMOTO, STAFFENBERG, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
00888118101372PLATE, CONSOLIDATION, FOR RAMUS TRANSPORT DEVICE, 1.5 MM SCREW, CP TITANIUM
00888118101228DIST, LEFORT 1, ZURICH TELE, RIGHT, 40 MM POSTERIOR BAR, 2.0-2.3 MM SCREW, TI-6AL-4V

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