DISTRACTION, INTERNAL, STERILE

GUDID 00888118114488

DIST, CRANIAL, ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V

KLS-Martin L.P.

Implantable craniofacial bone distractor

• Primary Device ID: 00888118114488
• NIH Device Record Key: 7071c24d-f3cd-4eaa-8e55-07a1713f1c23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISTRACTION, INTERNAL, STERILE
• Version Model Number: 51-563-40-71
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888118114488 [Primary]

FDA Product Code

• PBJ: Cranial Distraction System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-09-23
• Device Publish Date: 2018-01-12

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