DISTRACTION, INTERNAL, STERILE

GUDID 00888118129581

DIST, MANDIBLE, HYPERDRIVE, RTCH, 1.5-1.8 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

• Primary Device ID: 00888118129581
• NIH Device Record Key: 5441cc9f-53ed-4fd1-a0b2-59629addf878
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISTRACTION, INTERNAL, STERILE
• Version Model Number: 51-351-20-71
• 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: true
• 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
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888118129581 [Primary]

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-01
• Device Publish Date: 2021-10-22

On-Brand Devices [DISTRACTION, INTERNAL, STERILE]

• 10888118104110: SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
• 10888118104103: SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
• 10888118104097: SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.5 MM HEX DRIVER, TI-6AL-4V
• 10888118104080: SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
• 10888118104073: SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
• 10888118104066: SCREW, MAXDRIVE/HEX, ZURICH, DRILL FREE, 2.0 MM HEX DRIVER, TI-6AL-4V
• 00888118114785: SET SCREW, CONE CONNECT, MAXDRIVE, TI-6AL-4V
• 00888118114556: DIST, CRANIAL, ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118114549: DIST, CRANIAL, MICRO ZURICH 2, ARNAUD, END DRV, TOP RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118114532: DIST, CRANIAL, MICRO ZURICH 2, ARNAUD, END DRV, TOP RTCH, 2.0-2.3 MM SCREW, TI-6AL-4V
• 00888118114525: DIST, CRANIAL, MICRO ZURICH 2, ARNAUD, END DRV, 2.0-2.3 MM SCREW, TI-6AL-4V
• 00888118114518: DIST, CRANIAL, MICRO ZURICH 2, END DRV, RTCH, DETACH PLATES, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118114501: DIST, CRANIAL, MICRO ZURICH 2, FORREST, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118114495: DIST, CRANIAL, ZURICH 2, END DRV, OPP RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118114488: DIST, CRANIAL, ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118114471: DIST, CRANIAL, ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118114464: DIST, CRANIAL, MICRO ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118114310: DIST, CRANIAL, MICRO ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118107848: DIST, MANDIBLE, MICRO ZURICH 2, END DRV, OPP RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
• 00888118107831: DIST, MANDIBLE, MICRO ZURICH 2, END DRV, OPP RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
• 00888118107824: DIST, MANDIBLE, MICRO ZURICH 2, MID DRV, OPP RTCH, 1.0-1.2 MM SCREW, TI-6AL-4V
• 00888118105615: DIST, MANDIBLE, ZURICH 2, TLTS TRANS, HERFORD, RIGHT, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105608: DIST, MANDIBLE, ZURICH 2, TLTS TRANS, HERFORD, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105592: DIST, MANDIBLE, ZURICH 2, TLTS TRANS, STR, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105585: DIST, MANDIBLE, ZURICH 2, TLTS TRANS, STR, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105578: DIST, MANDIBLE, ZURICH 2, TLTS TRANS, STR, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105561: DIST, MANDIBLE, ZURICH 2, TLTS TRANS, STR, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105554: PLATE, TLCK TRANS, 1 HOLE FOR 2.7-3.2 MM SCREW, TI-6AL-4V
• 00888118105547: DIST, CLEFT, MICRO ZURICH 2, LIOU TRANS, RIGHT, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105530: DIST, CLEFT, MICRO ZURICH 2, LIOU TRANS, RIGHT, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105523: DIST, CLEFT, MICRO ZURICH 2, LIOU TRANS, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105516: DIST, CLEFT, MICRO ZURICH 2, LIOU TRANS, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105509: DIST, MANDIBLE, ZURICH 2, 3DX, WILLIAMS, U PLATE, RIGHT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105493: DIST, MANDIBLE, ZURICH 2, 3DX, WILLIAMS, U PLATE, RIGHT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105486: DIST, MANDIBLE, ZURICH 2, 3DX, WILLIAMS, U PLATE, LEFT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105479: DIST, MANDIBLE, ZURICH 2, 3DX, WILLIAMS, U PLATE, LEFT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105462: DIST, MANDIBLE, ZURICH 2, WILLIAMS, RIGHT ANGLE, RIGHT, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105455: DIST, MANDIBLE, ZURICH 2, WILLIAMS, RIGHT ANGLE, LEFT, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105448: DIST, LEFORT 3/MONO, MOLINA ORBITAL MALAR, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105431: DIST, CRANIO MANDIBLE FIXATOR, W/WEDGE, 18 MM STEP, 2.7 MM PIN, 2.0-2.3 MM SCREW, TI-6AL-4V
• 00888118105424: DIST, CRANIO MANDIBLE FIXATOR, W/WEDGE, 18 MM STEP, 2.7 MM PIN, 2.0-2.3 MM SCREW, TI-6AL-4V
• 00888118105417: DIST, CRANIO MANDIBLE FIXATOR, W/WEDGE, 15 MM STEP, 2.7 MM PIN, 2.0-2.3 MM SCREW, TI-6AL-4V
• 00888118105400: DIST, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V
• 00888118105394: DIST, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V
• 00888118105387: DIST, RAPID PALATAL EXPANDER 2, 2.0-2.3 MM SCREW, TI-6AL-4V
• 00888118105370: DIST, LEFORT 1, ZURICH 2, RIGHT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105363: DIST, LEFORT 1, ZURICH 2, RIGHT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105356: DIST, LEFORT 1, ZURICH 2, LEFT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105349: DIST, LEFORT 1, ZURICH 2, LEFT, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V
• 00888118105332: DIST, PALATAL, ROTTERDAM, NON SYNDROMIC, TI-6AL-4V