DISTRACTION, INTERNAL, STERILE

GUDID 00888118136640

SPRING, CRANIOXPAND, STAINLESS STEEL ASTM F138/9

KLS-Martin L.P.

Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal

• Primary Device ID: 00888118136640
• NIH Device Record Key: 3411aa07-5c9a-40fc-a0fe-429e15229b7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISTRACTION, INTERNAL, STERILE
• Version Model Number: 25-025-12-71
• Company DUNS: 826499238
• Company Name: KLS-Martin L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• 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 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	00888118136640 [Primary]

FDA Product Code

• PBJ: Cranial Distraction System

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: 2024-01-02
• Device Publish Date: 2023-12-25

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